System and method for mechanically positioning intravascular implants

ABSTRACT

An intravascular implant delivery system carries an implant by retaining an engagement member engaging the implant in a position proximal of an aperture at a distal end of the delivery system. The engagement member is retained proximal to the aperture by a cord that obstructs the movement of the engagement member through the aperture. The engagement member is free to rotate and move within an area defined by the delivery system, allowing the implant to react to forces imparted to the implant by the movement of the delivery system and implant through a delivery catheter. Once the implant is in a desired implant position, the cord is moved away from an aperture and the engagement member is allowed to move away from the delivery system.

PRIORITY DATA AND INCORPORATION BY REFERENCE

This application is a continuation of U.S. patent application Ser. No.12/297,419, filed Jul. 9, 2009, which is a national stage entry of PCTpatent application Ser. No. PCT/US07/66722, filed Apr. 16, 2007, andwhich claims priority benefit of U.S. Provisional Application Nos.60/792,414, filed Apr. 17, 2006, and 60/894,589, filed Mar. 13, 2007,each of which are incorporated by reference in their entireties, as iffully set forth herein.

TECHNICAL FIELD

This invention relates to therapeutic implant delivery and retrievalsystems and, more particularly, to a system with a member thatmechanically engages an implant to be positioned in a body. Thepositioning includes delivering and deploying an implant at a targetsite, or removing an implant from the target site. The invention alsorelates to implants and, more particularly, to implants adapted to bemechanically retained by a delivery and retrieval system.

BACKGROUND ART

Sometimes a body cavity, such as an aneurysm, is located in a surgicallyremote, delicate, and torturously formed region, such as within thecerebral vasculature, that requires a specialized delivery system tonavigate to the region and safely and reliably deliver a coil implant.

U.S. Pat. Nos. 5,122,136 and 5,423,829 describe some existingelectrolytic delivery systems having a pusher attached to an implantableplatinum coil by detachment segment that can be eroded by anelectrolytic process. The coil is advanced by the pusher through amicrocatheter to the desired target site within the vasculature and anelectrical current is applied to the pusher at the detachment segment.The electrical current causes the electrolytic erosion of the detachmentsegment that results in the separation of the coil from the pusher andthe release of the coil at the target site. It is believed that thereare numerous drawbacks and disadvantages to such electrolytic systems.One disadvantage of this design is believed to be that the detachmentsegment must be positioned distally of microcatheter for release (i.e.,the operator cannot “pre-release” the coil within microcatheter ifdesired). Another disadvantage is believed to be that these systemsrequire electrical insulation and isolation of the detachment segment toreduce the release of metallic particles created during detachment,which may cause unwanted embolization downstream of the target site.Another disadvantage is believed to be that these systems require thepractitioner to wait for an unknown amount of time, typically 10-180seconds, until the implant coil is released, with the release monitoredby feedback from a specialized system using complex electrical drivers.Yet another disadvantage is believed to be that these systems generate“false positives” quite often, at orate of 3-10%, that falsely indicatethat the coil has been released when in fact it has not. Further, aswith any electrochemical reaction in solution, the system needs to bewithin ionic fluids to function, and it is believed that undesirablegases are formed at both the anode and the cathode. Additionally, it isbelieved that there are guide wire and delivery system size limitationsbecause these systems require a constant flow of electrolytes such assaline through the microcatheter to hasten the detachment time of thecoil. Because of this need for electrolytes, it is believed that theouter diameter of an electrolytic delivery system is optimized forsaline flow rather than for considerations of coil deliverability,pushability, and force transfer of the pusher, and the suppleness of thedistal end of the delivery system.

U.S. Pat. Nos. 6,063,100 and 6,607,538 describe hydraulic deliverysystems having a pusher attached to an implantable platinum coil with africtional fit between a pressure cuff on the distal end of the pusherand a cylindrical solid proximal end of the coil. The platinum coil isadvanced through a microcatheter by the pusher into the target site.Hydraulic pressure is applied to the proximal end of the pusher,creating hydraulic pressure at the distal end of the pusher and causingthe cylindrical solid proximal end of the coil to be pushed out of thepressure cuff to cause the separation of the coil from the pusher. Onedisadvantage of this design is believed to be that such systems requirecomplex catheter construction and rigorous purging to avoid the deliveryof air emboli. Even after purging, it is believed that some air emboliare usually left in the system and will be inevitably injected into thepatient during the detachment process. Another disadvantage is believedto be that these systems are time consuming to use because of thepreparation of the pusher and because of the filling and attachment ofpressure syringes. These systems are believed to be less reliable thanelectrolytic systems and at times have either failed to release the coilor prematurely released the coil. Additionally, with this type ofdesign, it is believed that the delivery system is optimally sized forhydraulic detachment, and not sized to facilitate coil delivery or theaction of the pusher-coil interface. These delivery systems havegenerally hollow conduits designed for high hydraulic pressures and, asa result, are rigid. The coil-pusher interface, as well, is stiffbecause part of the proximal end of the coil is wedged tightly into thedistal end of the pusher.

U.S. Pat. No. 5,234,437 describes a mechanical delivery system with apusher that is attached to an implantable platinum coil by a threadedportion at the distal end of the pusher that screws into the inner windsof the coil. The coil is advanced by the pusher through a microcatheterinto the target site. Once positioned, the operator twists the proximalend of the pusher a number of times to unscrew the distal end of thepusher from coil implant. A disadvantage of this design is believed tobe that the system will not work well in highly tortuous anatomy due tothe diminishing torque transmission of the pusher, that is, the body ofthe pusher itself twists with little or no rotation of the threadedportion. The unscrewing operation of the pusher is also believed tocause undesirable movement of the entire system that could causemisalignment with the target site and cause the coil to be positionedundesirously within the target vessel. Also, the screw design isbelieved to require the operator to hyper-extend the pusher beyond thetip of the microcatheter to effect release and is non-retrievable atthat point.

U.S. Pat. No. 5,895,391 and U.S. Pat. Publ. No. 2006/0276823 describemechanical delivery systems, U.S. Pat. No. 5,895,391 describes a matingmember attached to a vaso-occlusive member that is held in an openingwith an interference wire. The interference wire presses the matingmember into an opening through the wall of a holding member. U.S. Pat.Publ. No. 2006/0276823 describes a mechanical interlocking mechanismwith engagement member attached to a distal end of a pusher member andthat extends through a retaining ring at a proximal end of an embolicdevice. A detachment member extends through an aperture at the distalend of the engagement member to lock the embolic device onto the pushermember.

Accordingly a need exists for an implant delivery system that is easierto use and more reliable than systems currently on the market and thatrequires fewer steps and faster detachment.

A further need exists for a technique for treating a vascular defect orlesion with platinum coils without creating metallic or gaseousparticulates during the detachment process.

A further need exists for an implant delivery system that has increasedreliability measured by fewer false positive detachments and fewerpremature detachments.

A further need exists for a coil-to-pusher interface that is less rigidthan those of existing systems.

A further need exists for an implant delivers system with superiorpushability with a supple distal flexibility profile.

DISCLOSURE OF INVENTION

The positioning system includes an actuator operated by an operator, apositioner engaging the actuator, and an implant interface at the distalend of the positioner that engages a complementary portion of animplant.

The positioner provides the operator the ability to controllably movethe implant through a microcatheter or delivery tube and to properlyposition the implant at a target site. The positioner provides amechanical system for selectively engaging the implant, whilemaintaining a narrow profile and sufficient flexibility to navigate thetortuous pathways within the body that are navigated to reach the targetsite. While providing a small and flexible profile, the positioner hassufficient strength to allow the operator to controllably move theimplant through the microcatheter, and the mechanical engagement withthe implant remains functional and controllable when subjected to hightortuosity near the target site. The mechanical engagement of thepositioner to the implant also maintains the proper orientation of theimplant throughout the positioning procedure by allowing the implant torotate and discharge any torsional forces induced during the movement ofthe implant to the target site. The positioner also allows the operatorto control the movement of the positioner and implant by properlytranslating the control exerted by the operator into predictable andresponsive movements near the target site.

The positioner achieves advantageous performance and overcomes problemsbelieved to be limiting the performance of existing systems by providinga mechanical implant engagement system that permits free rotatingmovement while retaining the implant, and that provides minimal directcontact with the implant, so as to minimize the build up of torsionalforces between the positioner and implant when the implant twists androtates while moving through the microcatheter. The contact between thepositioner and implant is minimized and fully rotatable so that theimplant will maintain an acceptable orientation as it progresses to thetarget site while independently reacting to any forces acting on theimplant when navigating the tortuous pathway to the target site. Theminimization of contact and torsional forces between the positioner andimplant improves the operator's ability to control the positioner, andimproves accuracy in the positioning of the implant at the target site.The positioner also achieves advantageous performance by providing amechanical implant engagement system that is narrow, flexible, andcontrollable. The positioner provides a narrow profile by employing amechanical implant engagement system in which the implant moves in anaxial direction when engaging or disengaging the positioner, without theneed for transverse movement of the implant. The positioner providesimproved flexibility by using a support structure that has varyingflexibility along its length, with greater flexibility corresponding tomore tortuous portions of the pathway to the target site. The positionerprovides improved controllability by employing materials and surfacesthat provide coefficients of friction selected with regard to thetortuosity of the pathway to the target site, and that are utilized inthe positioner so as to correspond to the most tortuous portions of thepathway to the target site. The positioner also provides improvedcontrol by more fully and accurately communicating the control movementsexerted by the operator to the movement of the positioner at the targetsite. The positioner also provides a system that permits the mechanicalengagement or disengagement of the implant without the use of hydraulic,thermal, electrical, or chemical energy.

The implant interface allows the operator to mechanically control theengagement and disengagement of the implant to the positioner, andallows the positioner to retain the implant in a way that minimallycontacts the implant, that permits movement in all directions of motionand rotationally, and that allows the implant to move axially andwithout radial movement when engaging and disengaging the implantinterface. The implant interface provides mechanical control of theengagement and disengagement of the implant by retaining a memberengaging the implant. The member is introduced into the implantinterface through an opening in the positioning system, and retained atthe implant interface by obstructing the opening at least in part, orfully, so as to physically prevent the complete exit of the member backthrough the opening. The obstructing is achieved with a movable elongatemember disposed along the length of the positioning system with a distalend that obstructs the opening. By obstructing the opening and notfixedly restraining the implant, the implant remains free to moveaccording to the limitations defined by the implant interface, whichincludes movement in the axial and radial directions compared to theaxis of the positioning system, rotational movement about an axis of theimplant, and angular movement that disposes the implant at an angle ascompared to the axis of the positioning system. Furthermore, byobstructing the opening and not directly restraining the implant, thecontact between the implant interface and the implant is minimized.

The therapeutic implant can be any implant that can be retained andpositioned by the positioning system. The implant is retained by theimplant interface with an extension engaging the implant. The extensioncan be a part of the implant when the implant is made, a modifiedportion of the manufactured implant, or attached to the implant afterinitial manufacturing. The extension provides an end that is disposed ata distance from the implant body, and allows the implant interface toengage and secure the implant by securing the end of the extension. Theimplant body itself; however, is not connected to the implant interface.The end of the extension is preferably a ball, but can take other forms.

The positioning system facilitates the unhindered rotation of the balland implant, thereby avoiding the sudden or uncontrolled release ofenergy imparted to the system by the movement of the system to thetarget site. The free rotation of the implant and ball allows theimplant to be deployed from the microcatheter at the target site muchmore gently than with existing systems having a connection that is rigidor that partly or wholly limits movement and rotation between theimplant and delivery system, and the free rotation also lowers the forceapplied to the vasculature during deployment and positioning of theimplant at the target site.

The implant interface also advantageously provides for the unrestrainedaxial movement of the bail within a cavity of the implant interface. Themovement of the ball within the cavity is related to the longitudinallength of the cavity and the length of the rod engaging the implant anddisposed in the cavity. When the implant and positioner are bothadvanced in the distal direction, friction against the surface of theimplant will cause the ball to move axially to an extreme proximalposition in the cavity and the proximal surface of the implant will abutthe distal surface of positioner. When the positioner is advanced in theproximal direction, friction against the surface of the implant willcause the ball to move distally to an extreme distal position in thecavity, and that there will be minimal or no frictional contact betweenthe positioner and implant. The differing frictional characteristicsrelated to the axial movement of the ball in the cavity, and the degreeof contact between implant and the implant interface, provides a“friction push” and a “frictionless pull” to the positioning system thatis appealing to the operator because it provides an additional tactilesensation related to the movement of the system.

The axial movement of the ball in the cavity advantageously permits theimplant to assume an angled orientation compared to the axis of thepositioner, and articulate or pivot around the ball. That angledorientation and articulation advantageously assists in the relaxationand discharge of potential energy or spring forces in the implant, orbetween the implant and the positioner, as the implant is moved throughthe microcatheter.

The positioner also advantageously captures or recaptures an implantalready located at or proximate the target site.

The actuator interface provides the operator the ability to control themovement of the implant as it is positioned by the positioning system,and to mechanically control the selective engagement and disengagementof the implant and implant interface. The actuator interface controlsthe movement of the implant by providing a surface upon which theoperator can exert control, so that the controlling motions of theoperator are accurately transferred to the implant interface and implantthrough the positioner. The actuator interface provides a relativelystiff proximal end of the positioner that transfers the axially-directedand rotational forces exerted on the actuator interface by the operatorto the relatively flexibly distal end of the positioning system withminimal loss due to flexing and twisting of the positioning system. Theactuator interface provides control of the engagement and disengagementof the implant from the implant interface with a sliding mechanism thatcontrollably and predictably moves the implant interface between theengaged and disengaged orientations. The actuator interface alsoconnects to an actuator that permits the operator to controllably andpredictably move the slider. In addition, the actuator interfaceestablishes and maintains a compressive biasing of the implant interfaceso that the implant interface remains in the engaged orientation bydisposing the slider in a distally forward position.

The actuator provides a mechanism that removably engages the actuatorinterface and causes the controllable and predictable movement of theactuator interface. The actuator achieves this function by providing astructure that holds the outer tube in a fixed position relative to thebody of the actuator, and a pawl and anvil that pinches the slider andpulls the slider in the proximal direction for a predetermined distancewith a predetermined force, and then disengages from the slider to allowdisengagement from the actuator. The actuator also provides a designthat allows the operator to hold the actuator firmly in place, in orderto maintain the position of the positioner relative to the target site,and allows the operator to utilize the actuator in a controlled mannerthat minimizes the movement of the positioner.

In order to minimize the force required from the operator, and to lessenthe potential for failure of instrument components, the positioningsystem advantageously achieves improved pushability. The force appliedto the proximal end of the positioner translates to an equal or nearequal force at the distal end of the positioner. The positioning systemalso advantageously achieves improved pushability by reducing frictionbetween the cord and the positioner, and between the positioner and themicrocatheter. Advantageous force transfer ratio is achieved by reducingthe average friction coefficient at the portions of the positioningsystem subject to the greatest tortuosity. This is achieved bypreferably selecting specific materials and surface characteristics ofmating surfaces at the portions of the positioning system subject to thegreatest tortuosity.

The positioning system achieves the appropriate level of flexibility bypreferably providing a relatively rigid structure at the proximalportion of the positioner, a relatively supple structure at the distalportion the positioner, and a transition region in the middle of thepositioner that provides a change in flexibility between the proximaland distal portions. The proximal portion of the positioner preferablyprovides a flexibility (or stiffness) that remains almost constant alongthe length of this section of the positioner. The near-constantflexibility of the proximal portion is achieved by the use of a tubestructure. The distal portion and the transition region achieve asuppleness with a combination of structural modifications to the tubestructure that increases flexibility, the increase in the degree ofthose structural modifications along the length of the tube structure inthe distal direction, and the structural support provided to thepositioner by reinforcing structures. The flexibility of the distalportion increases along the length of this section, with the greatestsuppleness achieved near or at the distal-most end of the positioner.The near-constant flexibility of the proximal portion is also achievedby a fully-enclosed tube structure of the positioner without the use ofskiving. The variable flexibility characteristics of the distal portionand the transition region are achieved by a combination of a tube withskiving, the increase in the degree of the skiving along the length ofthe tube in the distal direction, and the structural support provided tothe positioner by the positioner tube sleeve.

The positioning system achieves a mechanically-operated implantengagement and disengagement system with an appropriate profile, orsize, by utilizing materials and surfaces with variable frictioncoefficients, strengths, and flexibilities appropriate for a positionersubjected to a tortuous pathway. The outer diameter of the distal end ofthe positioner is small enough to reach the target site while permittingthe proper operation of the implant interface from a mechanical systemconnecting the implant interface to the proximal end of the positioningsystem.

The positioner avoids or minimizes the development of fatigue-relatedstresses at the interface between the positioner and implant bypermitting the unrestrained movement of the implant relative to thepositioner, within the limitations defined by the implant interface. Thedevelopment of implant interface stresses is minimized or avoidedbecause the ball, rod, and implant are able to move in the axial andradial directions compared to the axis of the positioning system, torotate about an axis of the rod or implant, and to move angularly sothat implant is at an angle as compared to the axis of the positioningsystem.

The positioning system does not require an additional step of preparinga coil detachment mechanism because the positioner and implant arealready in an engaged orientation when removed from packaging and priorto insertion into a patient. The positioner and implant thus provide asystem that is ready for use out of the package. The positioning systemalso provides a direct connection between the actuation of a detachmentmechanism and the detachment of the implant from the delivery system,without an intermediary process that must initiate and complete toachieve coil detachment. The positioning system thus achieves a fastpreparatory and/or detachment time, which represents a short period oftime between the opening of the packaging and the deployment of theimplant. The positioning system can be prepared for use without delaysrelating to the preparation of the coil detachment mechanism, and canachieve detachment of the implant from the positioning system withoutdelays resulting from an intermediate process that must be initiated andcompleted to achieve the detachment. The absence of such delays, and theconnection of the detachment mechanism, provides a system that permits afast and efficient deployment of implants at a target site. Thereduction in the length of time required to prepare the positioningsystem advantageously increases the efficiency of the procedure becausea coil detachment mechanism preparation step is not needed, therebyallowing the practitioner to attend to other duties during the invasivemedical procedure. The reduced deployment time advantageously allows thelength of the invasive medical procedure to be shortened because time isnot needed for the detachment mechanism to achieve coil detachment. Theshort deployment time also allows the expended positioner to be removedsoon after detachment and allow the next implant to be inserted andpositioned in a given time interval.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated herein and constitutepart of this specification, illustrate exemplary embodiments of theinvention, and, together with the general description given above andthe detailed description given below, serve to explain the features ofthe invention.

FIG. 1A is a plan view of the positioning system, and a plan view of anexemplary implant.

FIG. 1B is a closer view of a portion of FIG. 1A.

FIG. 2A is a plan view of the positioning system of FIG. 1A within thehuman body.

FIG. 2B is a closer view of a portion of FIG. 2A showing the positioningsystem in partial cross-section and an exemplary implant in a positionwithin the human body.

FIG. 2C is a closer view of a portion of FIG. 2A showing the positioningsystem in partial cross-section and an exemplary implant in anotherposition within the human body.

FIG. 3 is a plan cross-sectional view of the positioner of theembodiment illustrated in FIG. 1, and a plan view of a portion of anexemplary implant.

FIG. 4 is an isometric view of the positioner and exemplary implant ofFIG. 3, with the positioner shown in partial quarter section.

FIG. 5A is a plan view of the positioner tube of the embodiment of FIG.3.

FIG. 5B is a cross-sectional view of a portion of FIG. 5A.

FIG. 5C is a cross-sectional view of another portion of FIG. 5A.

FIG. 5D is an isometric view of the positioner tube of FIG. 5A.

FIG. 6A is a plan cross-sectional view of the implant interface ofanother embodiment, and a plan view of a portion of an exemplaryimplant.

FIG. 6B is an isometric view of the implant interface of FIG. 6A, withthe implant interface shown in partial quarter section.

FIG. 7A is an isometric view of portions of the positioner and implantof FIG. 3, with the positioner in an engaged orientation, and with thepositioner shown in partial quarter section.

FIG. 7B is an isometric view of portions of the positioner and implantof FIG. 3, with the positioner in a disengaged orientation, and with thepositioner shown in partial quarter section.

FIG. 8A is a plan cross-sectional view of the positioner and a plan viewof the implant of FIG. 7A.

FIG. 8B is a plan cross-sectional view of the positioner and a plan viewof the implant of FIG. 7B.

FIG. 8C is a plan cross-sectional view of portions of the positioner andimplant of FIG. 3, with the implant removed from the positioner.

FIG. 9 is an isometric view of the implant interface of yet anotherembodiment, and partial isometric view of an exemplary implant.

FIG. 10 is a plan cross-sectional view of the implant interface andpartial plan view of the implant of FIG. 9.

FIG. 11A is a cross-section view of the implant interface from FIG. 8A.

FIG. 11B is an alternative implant interface to the embodimentillustrated in FIG. 11A.

FIG. 11C is another alternative implant interface to the embodimentillustrated in FIG. 11A.

FIG. 12 is a plan cross-sectional view of a portion of the embodiment ofFIG. 3 in one orientation.

FIG. 13 is a plan cross-sectional view of a portion of the embodiment ofFIG. 3 in another orientation.

FIG. 14 is a plan cross-sectional view of an alternative embodiment tothe positioner of FIG. 3, and a plan view of the implant of FIG. 3.

FIG. 15 is a cross-section view from FIG. 14.

FIG. 16 is a cross-section view of an alternative to the embodimentillustrated in FIG. 15.

FIG. 17A is a plan view of an alternative implant.

FIG. 17B is a plan view of another alternative implant.

FIG. 18 is a plan cross-section view of another embodiment of theactuator interface of FIG. 3.

FIG. 19 is a plan cross-section view of yet another embodiment of theactuator interface of FIG. 3.

FIG. 20A is a plan cross-section view of still another embodiment of theactuator interface of FIG. 3 in a first orientation.

FIG. 20B is a plan cross-section view of still another embodiment of theactuator interface of FIG. 3 in a second orientation.

FIG. 21A is a plan partial cross-section view of the actuator of FIG. 3in a deactivated position.

FIG. 21B is a plan partial cross-section view of the actuator of FIG. 3in an activated position.

FIG. 22A is a isometric partial cross-section view of a portion of theactuator of FIG. 21A.

FIG. 22B is a isometric partial cross-section view of a portion of theactuator of FIG. 21B.

FIGS. 23A-23C illustrate flexibility profiles for existing systems andthe positioner illustrated in FIGS. 3 and 4.

FIG. 24 is a plan view of another embodiment of the positioning systemof FIG. 1 with partial cross-sectional views, and with a partialcross-sectional plan view of a preferred implant.

FIG. 25 is a plan cross-section view of another embodiment of theactuator interface of FIG. 3.

FIGS. 26A and 26B are schematic plan views of yet another embodiment ofthe actuator interface of FIG. 3, and of the actuator of FIGS. 21A-22B.

FIG. 27 is a plan partial cross-section view of another embodiment ofthe actuator of FIG. 3 in an activated position.

FIG. 28 is an isometric partially-exploded view of the actuator of FIG.27.

MODE(S) FOR CARRYING OUT THE INVENTION

As illustrated in FIGS. 1A and 1B, the positioning system 10 preferablyincludes an actuator 20 operated by an operator, a positioner 40engaging the actuator 20, and an implant interface 80 at the distal endof the positioner 40. A portion of the implant interface 80 engages acomplementary portion of an implant 90.

In the embodiment illustrated in FIGS. 1A and 1B, an operator uses aguide tube or guide catheter 12 to position a delivery tube ormicrocatheter 14 in a patient's vasculature, as illustrated in FIG. 2A.The procedure involves inserting the guide catheter 12 into thepatient's vasculature through an access point such as the groin, anddirecting the distal end 12 a of the guide catheter 12 through thevascular system until it reaches the carotid artery. After removing aguide wire (not shown) from the guide catheter 12, a microcatheter 14 isinserted into the guide catheter 12 and the distal end 14 a of themicrocatheter 14 subsequently exits the guide catheter distal end 12 aand is positioned near the target site 16, such as an aneurysm in thepatient's brain. As illustrated in FIGS. 2B and 2C, the microcatheter 14includes microcatheter markers 15 and 15 a that facilitate imaging ofthe distal end 14 a of the microcatheter 14 with common imaging systemsand, in the illustrated embodiment, the microcatheter markers 15 and 15a are made of a radiopaque material. After the distal end 14 a reachesthe target site 16, the positioning system 10 of the illustratedembodiment is then inserted into the microcatheter 14 to position theimplant interface 80 at the distal end of the positioner 40 near thetarget site 16, as illustrated in FIG. 2C. If the implant 90 is beingdelivered in the procedure, the implant 90 is attached to the implantinterface 80 prior to inserting the positioning system 10 into themicrocatheter 14. This mode of implant delivery is illustrated in FIGS.2A-2C. The delivery of the implant 90 is facilitated by disposing themicrocatheter marker 15 a near the target site 16, and aligning themicrocatheter marker 15 with a positioner marker 64 in the positioner 40which, when the two markers (markers 15 and 64) are aligned with eachother as illustrated in FIG. 2C, indicates to the operator that theimplant interface 80 is in the proper position for the release of theimplant 90 from the positioning system 10. After depositing the implant90 at the target site 16, a second implant 90 can be deposited at thetarget site 16 by removing the positioning system 10 from themicrocatheter 14 and inserting a second positioning system 10 with anattached second implant 90 into the microcatheter 14 in a manner similarto the method used with the insertion of the first implant 90. The sameprocedure can be used for a third implant 90 and subsequent implants ifclinically necessary. If the implant 90 is already in the patient's bodyto be retrieved or repositioned, the positioning system 10 is insertedinto the microcatheter 14 without the implant 90.

Positioner

The positioner provides the operator the ability to controllably movethe implant through the microcatheter and to properly position theimplant at the target site. The positioner provides a mechanical systemfor selectively engaging the implant, while maintaining a narrow profileand sufficient flexibility to navigate the tortuous pathways within thebody to reach the target site. While providing a small and flexibleprofile, the positioner has sufficient strength to allow the operator tocontrollably move the implant through the microcatheter, and themechanical engagement with the implant remains functional andcontrollable when subjected to high tortuosity near the target site. Themechanical engagement of the positioner to the implant also maintainsthe proper orientation of the implant throughout the positioningprocedure by allowing the implant to rotate and discharge any torsionalforces induced during the movement of the implant to the target site.The positioner also allows the operator to control the movement of thepositioner and implant by properly translating the control exerted bythe operator into predictable and responsive movements near the targetsite.

The positioner achieves advantageous performance and overcomes problemsbelieved to be limiting the performance of existing systems by providinga mechanical implant engagement system that permits free rotatingmovement while retaining the implant, and that provides minimal directcontact with the implant, so as to minimize the build up of torsionalforces between the positioner and implant when the implant twists androtates while moving through the microcatheter. The contact between thepositioner and implant is minimized and fully rotatable so that theimplant will maintain an acceptable orientation as it progresses to thetarget site while independently reacting to any forces acting on theimplant when navigating the tortuous pathway to the target site. Theminimization of contact and torsional forces between the positioner andimplant improves the operator's ability to control the positioner, andimproves accuracy in the positioning of the implant at the target site.The positioner also achieves advantageous performance by providing amechanical implant engagement system that is narrow, flexible, andcontrollable. The positioner provides a narrow profile by employing amechanical implant engagement system in which the implant moves in anaxial direction when engaging or disengaging the positioner, without theneed for transverse movement of the implant. The positioner providesimproved flexibility by using a support structure that has varyingflexibility along its length, with greater flexibility corresponding tomore tortuous portions of the pathway to the target site. The positionerprovides improved controllability by employing materials and surfacesthat provide coefficients of friction selected with regard to thetortuosity of the pathway to the target site, and that are utilized inthe positioner so as to correspond to the most tortuous portions of thepathway to the target site. The positioner also provides improvedcontrol by more fully and accurately communicating the control movementsexerted by the operator to the movement of the positioner at the targetsite. The positioner also provides a system that permits the mechanicalengagement or disengagement of the implant without the use of hydraulic,thermal, electrical, or chemical energy.

The positioner is an elongate, flexible structure that transfers thecontrolling force applied by the operator at the proximal end to theimplant interface at the distal end. As illustrated in FIGS. 3 and 4,the positioner 40 preferably includes a positioner tube 42 that is anelongate tube containing a lumen 44. At the proximal end of thepositioner tube 42 is an actuator interface 46 that has an outer tube 48fixed to the proximal end of the positioner tube 42. The proximal end ofthe outer tube 48 encloses a distal end of a slider 50 that slideswithin the outer tube 48. The slider 50 receives the proximal end of thecord 52, and pulls or pushes the cord 52 when moved by the operator.Proximal to the slider 50 is an end weld 51 connecting to theproximal-most end of the cord 52. The distal end of the positioner tube42 engages the implant interface 80 and terminates at an end cap 82. Theend cap 82 has a port 84 through which the lumen 44 communicates withthe exterior environment of the positioner 40 or the interior of themicrocatheter 14, depending on the position of the positioner 40 inrelation to the microcatheter 14. The end cap 82 also provides an endcap surface 83 that opposes the cord 52, and that prevents thedisengagement of the implant 90 from the implant interface 80. Asillustrated in FIG. 24, the proximal edges of the end cap 82 at the port84 are preferably rounded or chamfered.

As also illustrated in FIGS. 3 and 4, and illustrated in FIGS. 5A-5D,the positioner tube 42 has a central axis 54 and a wall 56 running thelength of the positioner tube 42. At the proximal end 42 a and distalend 42 b of the positioner tube 42, the wall 56 is circumferential andforms a fully enclosed tube around the lumen 44. A middle portion 58 ofthe positioner tube 42 has a wall 56 that is skived for most of thelength of the middle portion 58, where the wall 56 does not fullycircumferentially surround the lumen 44, as illustrated in FIGS. 5A, 5C,and 5D. “Skived” can also include a channel or a scalloped or gougedopening in the wall 56 of the positioner tube 42. In the skived sections60 of the middle portion 58, the wall 56 only partially encloses thelumen 44 and forms a longitudinal aperture exposing the lumen 44.Because the wall 56 in the skived sections 60 of the middle portion 58has less material, it is more flexible than the fully enclosed wall 56of the proximal and distal ends of the positioner tube 42 when subjectedto a bending force curving the axis 54 of the positioner tube 42 or to arotational force twisting the positioner tube 12 about the axis 54. Thethickness of the wall 56 also varies over the length of the positionertube 42, with a relatively thick wall 56 towards the proximal end 42 aand a relatively thin wall 56 towards the distal end 42 b, asillustrated in FIGS. 5B and 5C. As illustrated in FIGS. 5A and 5D, thedegree of skiving in the skived section 60 also varies along the lengthof the positioner tube 42, with greater skiving occurring towards thedistal end 42 b of the positioner tube 42.

At two points 62 along the length of the middle portion 58 there areareas where the wall 56 transitions from a partial wall to a full wallcircumferentially enclosing the lumen 44, similar to the wall 56 in theproximal and distal ends of the positioner tube 42. Between these twopoints 62 is a positioner marker 64, as illustrated in FIGS. 3 and 4,which is detectable by common imaging systems. Positioner marker 64 hasan outer diameter that is greater than the inner diameter of the lumen44, in order to maximize the visibility of the positioner marker 64 whenviewed with common imaging techniques. The two points 62 provide aprecise location along the length of the positioner tube 42 for thepositioning of the positioner marker 64, and prevent the positionermarker 64 from migrating during assembly or use. In use, the positionermarker 64 aids in the proper alignment of the positioner 40 with amicrocatheter marker 15 as illustrated in FIG. 2C, and indicates whenthe positioner 40 is in the correct position relative to themicrocatheter 14 for the disengagement of the implant 90. Preferably,one or both of the two points 62 are disposed at a predetermineddistance or distances from each other, from the end cap 82, from eitherend of the positioner tube 42, and/or from a positioner marker such asmarker 124. Most preferably, the predetermined distance is within a 0.2mm tolerance.

Referring to FIGS. 3 and 4, enclosed around the longitudinal length ofthe positioner tube 42 is a positioner tube sleeve 66 that provides asliding exterior surface to the positioner tube 42 that facilitates theinsertion and sliding of the positioner tube 42 into and through themicrocatheter 14. The positioner tube sleeve 66 increases lubricitybetween the positioner tube 42 and the inner lumen surface of themicrocatheter 14 and increases the structural integrity of thepositioner tube 42. It is particularly advantageous to reduce frictionbetween the positioner tube 42 and the microcatheter 14 at the distalone third of the positioning system 10 as this distal-most portion issubject to tortuous anatomy that causes additional friction betweenmoving components. The wall thickness of the positioner tube sleeve 66varies along its longitudinal length, and, as best illustrated in FIG.3, generally has a relatively thick wall thickness towards the distalend 42 b of the positioner tube 42, oppositely arranged as compared tothe varying thickness of the wall 56 of the positioner tube 42. Thecombination of the thickness of the wall of the positioner tube sleeve66 and the oppositely arranged thickness of the wall 56 of thepositioner tube 42 provides a consistent outer diameter of thepositioner 40 along portions of the length of the positioner 40, and aprofile that slidably engages the interior of the microcatheter 14. Asillustrated in FIG. 24, portions of the positioner tube sleeve 66preferably conforms to the shape of the structure contained within thesleeve, thereby having an smaller outer diameter where the sleeve 66covers the skived sections 60 of the positioner tube 42 as compared tothe larger outer diameter where the sleeve 66 covers non-skived sectionsof the positioner tube 42. As also illustrated in FIG. 24, thepositioner tube sleeve 66 preferably covers only the distal half of thepositioner 40. As further illustrated in FIG. 24, the skived sections 60preferably includes multiple skived sections that are identified asskived sections 60 a, 60 b, and 60 c, with one or all of the skivedsections disposed at a predetermined distance from each other, from theend cap 82, from either end of the positioner tube 42, and/or from apositioner marker such as marker 124.

A cord liner 68 disposed upon the inner surface of positioner tube 42within the lumen 44 encloses the cord 52 to provide a sliding surfacethat guides the cord 52, preferably along the axis 54. The cord liner 68also passes through the interior of the positioner marker 64, reducingin diameter where it engages the positioner marker 64. It isadvantageous to insert a low-friction material between the surface ofthe cord 52 and the positioner tube 42 in order to reduce the frictionaldrag acting on the cord 52 when moved within the positioner tube 42. Itis particularly advantageous to reduce friction at the distal one thirdof the positioner tube 42 and the cord 52 as these distal-most portionsare subject to tortuous anatomy causing additional friction between thecord 52 and the cord liner 68.

The cord 52 slides within the lumen 44, and the lumen of the cord liner68, from the actuator interface 46 to the implant interface 80. Asillustrated in FIGS. 3 and 4, at the implant interface 80, thepositioner tube 42 encloses a stopper 70 fixed within the inside of thepositioner tube 42 near where the positioner tube 42 transitions from askived portion to a fully-enclosed portion. The stopper 70 functions toguide and control the movement of the distal portion of the cord 52.Just proximal of the stopper 70, the cord 52 is limited from furtherdistal movement within the positioner tube 42 by a coining area 72,which is an enlarged portion of the cord 52 that is too large to passdistally through the central lumen of the stopper 70. The configurationof the stopper 70 and coining area 72 allows the cord 52 to becompressively biased in the distal direction against the stopper 70,which aids in assembly and maintains the distal end of the cord 52 in adistally forward position. The compression of the cord 52 can cause aportion of the cord 52 to flex and assume a position that is adjacent tothe axis 54, and possibly against the inner surface of positioner tube42.

More preferably, the positioner tube 42 is made from a material that isflexible and strong enough to transfer forces applied by the operator atthe proximal end to the implant interface 80, such as 304 stainlesssteel hypotube, polymeric extrusion, braided extrusion, ornon-elongating polymeric material that has a 0.010-0.018 inch outerdiameter and a 0.005-0.012 inch inner diameter, with a 10-60 cm lengthof the distal end of the positioner tube 42 ground to a 0.008-0.016 inchouter diameter to reduce girth and increase flexibility. The outer tube48 is more preferably made of 304 stainless steel hypotube, polymericextrusion, braided extrusion, or non-elongating polymeric material witha 0.012-0.020 inch outer diameter, a 0.010-0.018 inch inner diameter,and a length of 1-15 cm, fitted over the proximal 1-50 mm of thepositioner tube 42 and circumferentially welded to the positioner tube42. The slider 50 is more preferably made of a 304 stainless steelhypotube segment, polymeric extrusion, or steel alloys and crimped tothe proximal end of the cord 52, with a 0.010-0.018 inch outer diameter,a 0.001-0.016 inch inner diameter, and a length of 1-15 cm. The end cap82 is more preferably made of a 0.001-0.005 inch thick 304 stainlesssteel, polymeric material, or steel alloy retainer ring with a0.008-0.018 inch outer diameter and a 0.003-0.009 inch diameter portwelded or bonded to the distal end of the positioner tube 42. Thepositioner marker 64 is more preferably a radiopaque platinum/iridium orplatinum/tungsten coil disposed in the lumen 44 and having a 0.008-0.018inch outer diameter, a 0.005-0.015 inch inner diameter, and a 1-6 mmlength. The positioner tube sleeve 66 is more preferably made of apolytetrafluoroethylene (PTFE) or low-friction polymeric material havinga friction coefficient of 0.2 or less, heat shrunk onto all or at leastthe distal most portion of the positioner tube 42. The cord liner 68 ismore preferably made of PTFE or other low-friction materials and has a0.002-0.006 inch inner diameter and a 0.004-0.008 inch outer diameter.The cord 52 is more preferably a cord, wire, rod, tube, thread orfilament made of a metal or polymer with a circular cross section and a0.001-0.005 inch outer diameter. The stopper 70 is more preferably madeof 304 stainless steel, polymeric extrusion, braided extrusion, ornon-elongating polymeric material with approximately a 0.001-0.012 inchinner diameter, and is welded to the interior of the positioner tube 42.The coining area 72 more preferably has a 0.0015-0.0120 inch width. Thelength of the cord 52 proximal to the stopper 70 (e.g., between theproximal end of the positioner tube 42 and the proximal end of thestopper 70) is more preferably slightly longer than the correspondinglength of the structure adjacent to the length of the cord 52 (e.g., thelength of positioner tube 42 corresponding to the length of the cord 52)by 0.001-0.040 inches, thereby compressively biasing the cord 52 so thatit maintains the coining area 72 against the stopper 70 until the cord52 is moved in the proximal direction.

Most preferably, the positioner tube 42 is made from 304 stainless steelhypotube and has a 0.012 inch outer diameter and 0.007 inch innerdiameter, and a 50-60 cm length of the distal end of the positioner tube42 is ground to a 0.010 inch outer diameter to reduce girth and increaseflexibility. The outer tube 48 is most preferably made of 304 stainlesssteel hypotube with a 0.016 inch outer diameter, a 0.0122 inch innerdiameter, and a length of 6 cm, fitted over the proximal 5 mm of thepositioner tube 42 and circumferentially welded to the positioner tube42. The slider 50 is most preferably made of a 304 stainless steelhypotube segment crimped to the proximal end of the cord 52, with a0.012 inch outer diameter, a 0.003 inch inner diameter, and a length of4 cm. The end cap 82 is most preferably a 0.002-0.003 inch thick 304stainless steel retainer ring with an approximate 0.010 inch outerdiameter and an approximate 0.0043 inch diameter port welded to thedistal end of the positioner tube 42. The positioner marker 64 is mostpreferably a radiopaque platinum/tungsten coil disposed in the lumen 44and having an 0.008 inch outer diameter, a 0.006 inch inner diameter,and a 3 mm length. The positioner tube sleeve 66 is most preferably madeof PTFE. heat shrunk onto most of the length of the positioner tube 42.The cord liner 68 is most preferably made of PTFE and has a 0.003 inchinner diameter and a 0.005 inch outer diameter. The cord 52 is mostpreferably a 304 stainless steel Hyten™ cord sold by Fort Wayne Metalsof Indiana, with a circular cross section and an 0.00185 inch outerdiameter. The stopper 70 is most preferably made of 304 stainless steelwith a 0.0022 inch inner diameter, and is welded to the interior of thepositioner tube 42. The coining area 72 most preferably has a 0.0028inch width. The length of the cord 52 between the proximal end of thepositioner tube 42 and the proximal end of the stopper 70 is mostpreferably longer than the corresponding length of the positioner tube42 by 0.027 of an inch, thereby compressively biasing the cord 52 sothat it maintains the coining area 72 against the stopper 70 until thecord 52 is moved in the proximal direction.

Although specific materials, dimensions, and characteristics aredescribed in regard to the illustrated embodiments, it is appreciatedthat alternative designs can achieve the same operational objectives ofthe described components and structures. For example, to control theflexibility of the positioner tube 42, instead of skived sections 60 ofthe wall 56 at the middle portion 58, the wall 56 can fully or partiallyenclose the lumen 44 and include a plurality of slots or gaps toincrease the flexibility of the wall. The slots or gaps can have a depththat reaches through the entirety of the wall 56 to form holescommunicating with the lumen 44, or the slots and gaps can have a depththat reaches only partially into the surface of the wall 56. The slotsor gaps can be longitudinal and parallel with the axis 54, transverse ororthogonal to the axis 54, or at an angle to the axis 54. Instead ofslots or gaps, the wall 56 can have circular or oval holes partially orfully through the wall 56. In another alternative, the middle portion 58of the wall 56 can have a spiral cut along all or part of the length ofthe middle portion 58 to increase the flexibility of the wall. In yetanother alternative, the thickness of all or part of the wall 56 in themiddle portion 58 can be reduced to increase flexibility. In stillanother alternative, instead of a tube or a skived tube, the positionertube 42 can have a series of tubes and/or partial tubes longitudinallyaligned with a stiffening member between the tubes and/or partial tubes.Likewise, the end cap 82 can be replaced by a partial or whole loop,ring, or eyelet defining a port 84, and/or carried by a stiffeningmember disposed at a distance from the positioner tube 42.

In another alternative, instead of the end cap 82, the distal end of thepositioner tube 42 can be formed to have an end crimp, cone shape, ordome shape to reduce the diameter of the distal end of the positionertube 42 and form the port 84, and to also form a surface that engagesthe cord 52 and implant 90 to prevent the disengagement of the implant90 from the implant interface 80. An alternative in which the end cap 82is replaced with an end dome 81, made from the crimping of the distalend of the positioner tube 42, is illustrated in FIGS. 6A and 6B.

In yet another alternative, instead of a positioner tube sleeve 66, theexterior of the positioner tube 42 or the interior of the microcatheter14 can be coated with a lubricating material or a lubricant. Also,instead of being disposed on the inner surface of the lumen 44, the cordliner 68 can be disposed on a portion of the cord 52. In anotheralternative, the exterior of the cord 52 or the inner surface of lumen44 can be coated with a lubricating material or a lubricant.

In vet another alternative, instead of the coining area 72, the outerdiameter of the cord 52 at the position of the coining area 72 can bemade larger than the lumen of the stopper 70 by fixing a bushing to thecord 52. In another alternative, instead of modifying the dimensions ofthe cord 52 at the coining area 72 to limit its distal movement throughthe lumen of the stopper 70, the cord 52 can instead be provided with abend or twist that impedes the distal movement of the cord 52 into thelumen of the stopper 70. Yet another alternative is for the cord 52 tobe fixed in a distally forward position by an adhesive that can bebroken when the cord 52 is subjected to sufficient force.

Another aspect of the compressively biased arrangement that maintains aportion of the cord 52 in a distally forward position, at coining area72 and its alternatives, is that the positioner tube 42 must besufficiently strong to maintain the arrangement so that the distal endof the cord does not leave its position proximate the port 84 or permitthe premature release of the ball 96 from the cavity 86. Preferably, thepositioner tube 42 can maintain the position of the cord 52 relative tothe port 84 when subjected to an elongation force of more than 3Newtons, and more preferably, an elongation force of more than 2Newtons.

Implant Interface

The implant interface allows the operator to mechanically control theengagement and disengagement of the implant to the positioner, andallows the positioner to retain the implant in a way that minimallycontacts the implant, that permits movement in all directions of motionand rotationally, and that allows the implant to move axially andwithout radial movement when engaging and disengaging the implantinterface. The implant interface provides mechanical control of theengagement and disengagement of the implant by retaining a memberengaging the implant. The member is introduced into the implantinterface through an opening in the positioning system, and retained atthe implant interface by obstructing the opening at least in part, orfully, so as to physically prevent the complete exit of the member backthrough the opening. The obstructing is achieved with a movable elongatemember disposed along the length of the positioning system with a distalend that obstructs the opening. By obstructing the opening and notfixedly restraining the implant, the implant remains free to moveaccording to the limitations defined by the implant interface, whichincludes movement in the axial and radial directions compared to theaxis of the positioning system, rotational movement about an axis of theimplant, and angular movement that disposes the implant at an angle ascompared to the axis of the positioning system. Furthermore, byobstructing the opening and not directly restraining the implant, thecontact between the implant interface and the implant is minimized.

As illustrated in FIGS. 3 and 4, the cord 52 is preferably disposed atthe implant interface 80. A distal tip 88 of the cord 52 is positionedin the port 84 of the end cap 82 so that it partially obstructs the port84 when the cord 52 is at its most distally advanced position in thepositioner tube 42. The distal tip 88 is preferably deformable so thatit can be offset from the axis 54 of the positioner tube 42 and enterthe port 84 near the edge of the port. The positioner tube 42, the endcap 82, and the distal surface of the stopper 70 define a cavity 86within the implant interface 80.

The cord 52 preferably has engaged and disengaged orientationsillustrated, respectively, in FIGS. 7A and 7B. In the engagedorientation illustrated in FIG. 7A, the cord 52 is at its most distallyadvanced position in the positioner tube 42 with, in the illustratedembodiment, the coining area 72 abutting the stopper 70. The distal tip88 of the cord 52 is disposed within the port 84 in the end cap 82, andthe cord 52 is maintained in the engaged orientation by the actuatorinterface 46. In the disengaged orientation illustrated in FIG. 7B, thecord 52 has been moved in the proximal direction relative to thepositioner tube 42, with the coining area 72 disposed at a distanceproximal to the stopper 70. The distal tip 88 of the cord 52 is proximalof the port 84 in the end cap 82 and no longer obstructing or fullyobstructing the port 84, and the cord 52 is maintained in the disengagedorientation by the actuator interface 46. After achieving the disengagedorientation, a ball 96 carried by a rod 94 and engaging the implant 90is free to move distally through the port 84 or, alternatively, thepositioner tube 42 or the entire positioner 40 can be moved in theproximal direction to allow the ball 96 to exit the positioner tube 42.The engaged orientation, disengaged orientation, and the exit of theball 96 from the implant interface 80 are illustrated in FIGS. 8A, 8B,and 8C, respectively. As illustrated in FIG. 24, the proximal edges ofthe end cap 82 at the port 84 are preferably rounded or chamfered tofacilitate the exit of the ball 96 from the implant interface 80.

In an alternative embodiment illustrated in FIGS. 9 and 10, the distaltip 88 of the cord 52 is not disposed in the port 84 of the end cap 82but instead abuts against the proximal end cap surface 83 of the end cap82 in the engaged orientation illustrated in FIGS. 9 and 10. Thediameter or thickness of the distal tip 88 is sufficient to obstruct theport 84 in the engaged orientation, and the proximal movement of thedistal tip 88 removes the obstruction from the proximal edge of the port84 to assume the disengaged orientation illustrated in FIG. 7B. Sincethe end cap 82 provides an abutting end cap surface 83 that opposes thedistal movement of the cord 52, the obstruction of the port 84 can beachieved with or without the stopper 70 and coining area 72, and thecord liner 68 can be disposed more distally into the implant interface80, as illustrated in FIGS. 9 and 10. The compressive biasing of thecord 52 can be maintained by compressing the distal tip 88 against theend cap surface 83 of the end cap 82, and the cavity 87 can be definedby positioner tube 42, the end cap 82, the end cap surface 83, and thedistal surface of the cord liner 68.

Implant

The implant can be any implant that can be retained and positioned bythe positioning system. The implant is retained by the implant interfacewith an extension engaging the implant. The extension can be a part ofthe implant when the implant is made, a modified portion of themanufactured implant, or attached to the implant after initialmanufacturing. The extension provides an end that is disposed at adistance from the implant body, and allows the implant interface toengage and secure the implant by securing the end of the extension. Theimplant body itself, however, is not connected to the implant interface.

In the embodiment illustrated in FIGS. 1A-1B and 2B-4, the implant 90 isa neurological coil. The neurological coil implant 90 illustrated inFIGS. 1A-1B is shown in a coiled orientation prior to insertion into themicrocatheter 14, and the neurological coil implant 90 shown in FIGS.2B-4 is shown in a truncated form for simplicity and disposed inalignment with the axis 54 and the interior of the microcatheter 14 (notshown in FIGS. 2B-4). The neurological coil implant 90 shown in FIG. 2Cis shown in an implanted state, disposed in an aneurysm. The implant 90preferably has a rod 94 engaging the implant 90 in the proximaldirection, with the rod 94 including an eyelet 110 engaging astretch-resistant member 112, as illustrated in FIG. 24. Morepreferably, the stretch-resistant member 112 can pass through the eyelet110 and wrap the eyelet 110 to form a knot and, most preferably, form ahitch knot. As illustrated in FIGS. 3-4, when engaging the implantinterface 80, the rod 94 is disposed in the port 84 in the end cap 82and terminates with the ball 96 disposed proximal of the end cap 82 inthe cavity 86. The ball 96 has a cross sectional area that is less thana cross sectional area of the port 84, which allows the ball 96 to passfreely through the port 84 when the positioner 40 is in the disengagedorientation illustrated in FIG. 7B. When in the engaged orientationillustrated in FIGS. 3-4 and 7A, the distal tip 88 of the cord 52obstructs a portion of the port 84 in the end cap 82, with anotherportion of the port 84 obstructed by the rod 94. The obstruction of theport 84 by the distal tip 88 reduces the available area of the port 84so that the ball 96 can not pass through the port 84. Althoughphysically obstructed from passing distally through the port 84 when thecord 52 is in the engaged orientation, the ball 96 and rod 94 areotherwise unrestrained and free to move and rotate within the cavity 86and the port 84. Also, the ball 96 is retained at the implant interface80 but not connected to any portion of the positioning system 10. Theball 96 is thus free to move independently of the positioning system 10in any direction within the confines of the cavity 86 and, particularly,is free to move in the direction parallel or radial to the axis 54 ofthe positioner tube 42, free to move in to a position in which a centralaxis of the implant 90 is at an angle relative to the axis 54, and freeto rotate around the central axis of the implant 90.

The freedom to rotate the ball 96 and implant 90, facilitated by theillustrated embodiment, is advantageous. It is believed that in existingsystems, the implant or a portion of the implant is firmly held by thedelivery system and not free to rotate and, when the implant anddelivery system are advanced distally to the target site through amicrocatheter, the surface of the implant (especially the helicalsurface of some neurological coils) can induce a torque within theimplant when moved along the inner surface of a microcatheter. Thattorque is stored as a potential energy in a compressed spring within theimplant itself and within the connection between the implant and thedelivery system. When the implant then emerges from the microcatheter atthe target site, it is believed that the potential enemy can be releasedsuddenly and cause the implant to twist unpredictably and deposit itselfin an undesirable location. The positioning system 10 facilitates theunhindered rotation of the ball 96 and implant 90, thereby avoiding thisproblem that is believed to exist with existing delivery systems. Thefree rotation of the implant 90 and ball 96 allows the implant 90 to bedeployed from the microcatheter 14 at the target site 16 much moregently than with existing systems having a connection that is rigid orthat partly or wholly limits movement and rotation between the implantand delivery system, and the free rotation also lowers the force appliedto the vasculature during deployment and positioning of the implant 90at the target site 16.

The relationship between the implant interface and the implantestablishes some of the dimensions of these components. The implantinterface provides an opening having a first opening area and a secondopening area. The implant provides an extension that is disposed in theimplant interface through the opening, and that has a portion (such asthe ball 96) that can pass through the first opening area but can notpass through the second opening area. The portion of the extension hasan obstruction dimension that defines a structural arrangement thatprevents the portion from passing through the structure defining thesecond opening area at the opening. The obstruction dimension alsodefines the structural arrangement that permits the portion to passthrough the structure defining the first opening area. This relationshipcan be expressed as follows:first opening area>obstruction dimension>second opening area  Equation(1)The implant interface and implant extension use this relationship byhaving implant interface structure that forms the second opening area tobe smaller than the obstruction dimension of the implant extension, tophysically block passage of the portion of the extension through theopening, and implant interface structure that forms the first openingarea to be larger than the obstruction dimension, to allow passage ofthe portion of the extension through the opening.

In the embodiment illustrated in FIG. 11A, the principles of Equation(1) can be applied to relate the size of the ball 96 to the dimensionsof the port 84 and distal tip 88 of the cord 52 by the followingrelationship:p>b>(p−w)  Equation (2)where “p” is the cross sectional dimension of the port 84, “b” is thecross sectional dimension of the ball 96, and “p−w” is the crosssectional dimension of the port 84 less the cross section dimension ofthe distal tip 88 of the cord 52. In the illustrated embodiment, therelationship of Equation (2) is applied to structures having circularcross sections. However, it is appreciated that the principles ofEquation (1) can be applied to structures having non-circulargeometries, such as a rod 95, with a triangular cross section, or ports85 and 89, with a non-circular shape, as illustrated in FIGS. 15 and 16.

In alternative embodiments, the ball 96 can be replaced with anotherstructure that can effectively pass through an unobstructed port 84 butnot pass through an obstructed port 84, such as a disc, hook, or ringstructure. Likewise, the distal tip 88 can be modified to obstruct onlyselected portions of the port 84, or to more closely abut against theinner surface of positioner tube 42 within cavity 86 in order to providea larger space for the ball 96 to freely rotate or otherwise move withinthe cavity 86. In another alternative, the distal tip 88 can have across-sectional shape that is noncircular. For example, as illustratedin FIG. 11B, the cross-section shape of the distal tip 88 can be ovoidand, as illustrated in FIG. 11C, the cross-section shape of the distaltip 88 can be arcuate. Also, in another alternative, the rod 94 canengage the implant 90 at an angle relative to a central axis of theimplant 90, or at an angle relative to the axis 54 of the positionertube 42.

The illustrated embodiment advantageously provides for the unrestrainedaxial movement of the ball 96 within the cavity 86 of the implantinterface 80. The movement of the ball 96 within the cavity 86 isrelated to the longitudinal length of the cavity 86 and the length ofthe rod 94 engaging; the implant 90 into the cavity 86. As illustratedin FIG. 12, the rod 94 is of sufficient length to allow the axialmovement of the ball 96 and implant 90 in the direction of the axis 54of the positioner tube 42. When the implant 90 and positioner tube 42are both advanced in the distal direction, as illustrated in FIG. 12, itcan be appreciated that friction against the surface of the implant 90will cause the ball 96 to move axially to an extreme proximal positionin the cavity 86 and the proximal surface of the implant 90 will abutthe distal surface of the end cap 82 and align the implant 90 with theaxis 54 of the positioner tube 42. When distally advanced, with theimplant 90 abutting the end cap 82, there is a slight frictionaladhesion where the implant 90 and the end cap 82 contact each other.When the positioner tube 42, or implant 90 and positioner tube 42, areadvanced in the proximal direction as illustrated in FIG. 13, it canalso be appreciated that friction against the surface of the implant 90will cause the ball 96 to move distally to an extreme distal position inthe cavity 86, and that there will be minimal or no frictional contactbetween the end cap 82 and the implant 90. The differing frictionalcharacteristics related to the axial movement of the ball 96 in thecavity 86, and the degree of contact between implant 90 and the implantinterface 80, provides a “friction push” and a “frictionless pull” tothe positioning system 10 that is appealing to the operator because itprovides an additional tactile sensation related to the movement of thesystem. It is believed that existing systems that do not permit axialmovement of the implant, or that do not provide a reduced or variablefriction or frictionless interaction between the implant and deliverysystem, provide the operator less tactile sensation when moving theseexisting delivery systems.

Also, the axial movement of the ball 96 in the cavity 86 advantageouslypermits the implant 90 to assume an angled orientation compared to theaxis 54 of the positioner tube 42, and articulate or pivot around theball 96. As illustrated in FIG. 13, the rod 94 can be disposed at anangle 98 to the axis 54 of the positioner tube 42, and that angle 98 isincreased as the ball 96 nears an extreme distal position in the cavity86. That angled orientation and articulation advantageously assists inthe relaxation and discharge of potential energy or spring forces in theimplant 90, or between the implant 90 and the positioning system 10, asthe implant is moved through the microcatheter 14. The angulation canpreferably be approximately 10-50 degrees between the centerline of therod 94 and the axis 54 of the positioner tube 42, and more preferably beapproximately 30 degrees. Also, when the implant 90 is observed to havean angled orientation with an imaging system, the operator can readilydetermine that the implant 90 is not experiencing potential energy orspring forces that could be later released when the implant 90 isdeposited at the target site 16. It is believed that existing deliverysystems that do not permit angulation or articulation of the implant donot provide this information to the operator.

In an alternative embodiment illustrated in FIGS. 14-15, the port 85 ofthe end cap 82 can be non-circular or have a notch that advantageouslypermits a greater angulation or articulation than can be achieved withthe circular-shaped port 84, permitting, an angle 99 between thecenterline of the rod 94 and the axis 54 of the positioner tube 42.Similarly, the rod can have various cross-sectional shapes, such as atriangular shape of rod 95 as illustrated in FIG. 16, that interfaceswith a complimentary-shaped port 89 in order to maintain a specificarticulation (by the alignment of the triangular shape of rod 95 with atriangular notch of port 89) when the implant interface 80 is operatedto orientate the rod 95 so that the implant 90 is disposed in a specificdirection. It can be appreciated, that a slight proximal movement ofpositioner 40 may be necessary to maintain sufficient contact betweenthe rod 95 and the port 89 illustrated in FIG. 16. As also can beappreciated from FIGS. 13-16, the angulation can also be increased ordecreased by the adjusting the inner diameter of the port 84 or byadjusting the thickness of the end cap 82. Specifically, a greater innerdiameter of the port 84 will allow the rod 94 to assume a greater angle98, and a thinner end cap 82 will allow the ball 96 to assume a moredistal position in the cavity 86 and permit a greater angle of the rod94 through the port 84. As can be further appreciated, a desiredangulation can be preset in the design of the implant interface 80 bycontrolling the length and cross-sectional dimensions of the rod 94, thediameter of the port 84, and the thickness of the end cap 82. Also, forexample, the port 84 can have a conical shape or a shape in which oneend of the port 84 is wider than the other end of the port 84, so thatthe rod 94 can assume a greater or a preset angle relative to thepositioner 40.

The positioning system 10 of the illustrated embodiment alsoadvantageously captures or recaptures an implant 90 already located ator proximate the target site 16. As can be appreciated in the reversesequence of FIGS. 8A-8C, in the order of 8C to 8B to 8A, with thedirectional arrows of FIGS. 8B and 8C reversed, the positioner tube 42can be advanced distally through the microcatheter 14 (without theimplant 90) to an implant 90 already positioned at the target site 16or, if the implant 90 was just released from the implant interface 80,the positioner tube 42 can be maneuvered proximate to the just-releasedimplant 90. As can also be appreciated from FIG. 8C, the end cap 82 canbe moved over the ball 96 so that the ball 96 passes through the port 84and into the cavity 86 of the implant interface 80, and the distal tip88 of the cord 52 can be distally advanced to obstruct the port 84 toretain the ball 96 and assume the engaged orientation. The implant 90can then be moved or entirely withdrawn from the target site 16. In analternative embodiment, the ball 96 and end cap 82 can be made of amaterial that can be imaged with standard imaging technologies, such asa radiopaque material, in order to assist with the positioning of theend cap 82 in relation to the ball 96.

Commercially available embolic coils suitable for use with the deliverysystem 10, when modified to include the ball 96 or a combination of therod 94 and ball 96, include the Sapphire™, NXT™, and Nexus™ emboliccoils, commercially available from EV3, Inc. of Plymouth, Minn. USA.Although the implant 90 of the illustrated embodiment is a neurologicalcoil, the implant 90 can be any implant that can be inserted, with acatheter, such as a stent or stent-graft 90 a as illustrated in FIG. 17Aor an embolic filter 90 b as illustrated in FIG. 17B. Commerciallyavailable stents suitable for use with the delivery system 10, whenmodified to include the ball 96 or a combination of rod 94 and ball 96,include the IntraCoil®, IntraStent®, ParaMount™, PRIMUS™, and PROTÉGÉ®stents, commercially available from EV3, Inc. of Plymouth, Minn. USA. Acommercially available embolic protection device suitable for use withthe delivery system 10, when modified to include the ball 96 or acombination of rod 94 and ball 96, is the SpideRX® embolic protectiondevice, commercially available from EV3, Inc. of Plymouth, Minn. USA,

Actuator Interface

The actuator interface provides the operator the ability to control themovement of the implant as it is positioned by the positioning system,and to mechanically control the selective engagement and disengagementof the implant and implant interface. The actuator interface controlsthe movement of the implant by providing a surface upon which theoperator can exert control, so that the controlling motions of theoperator are accurately transferred to the implant interface and implantthrough the positioner. The actuator interface provides a relativelystiff proximal end of the positioner that transfers the axially-directedand rotational forces exerted on the actuator interface by the operatorto the relatively flexibly distal end of the positioning system withminimal loss due to flexing and twisting of the positioning system. Theactuator interface provides control of the engagement and disengagementof the implant from the implant interface with a sliding mechanism orslider that controllably and predictably moves the implant interfacebetween the engaged and disengaged orientations. The actuator interfacealso connects to an actuator that permits the operator to controllablyand predictably move the slider. In addition, the actuator interfaceestablishes and maintains a compressive biasing of the implant interfaceso that the implant interface remains in the engaged orientation bydisposing the slider in a distally forward position.

The compressive biasing of the cord 52 that presses the coining area 72distally against proximal end of the stopper 70 is preferablyestablished at the actuator interface 46. In the embodiment illustratedin FIG. 3, the proximal end of the positioner tube 42 is fixed to theouter tube 18 by a circumferential weld. The slider 50 is slidablyfitted into the lumen of the outer tube 48 from the proximal end of theouter tube 48. The cord 52 is then preloaded or biased in the distaldirection to create compression in the cord 52 in the coining area 72against the stopper 70 and the slider 50 is tack welded with tack weld49 to the outer tube 48 while preloaded, to temporarily fix the slider50 and outer tube 48 together and maintain the implant interface 80 inthe engaged orientation. When the disengaged orientation is desired, theoperator slidably moves the slider 50 in the proximal direction,relative to the outer tube 48, with sufficient force to break the tackweld 49 and free the slider 50 so that it can move within outer tube 48.More preferably, a tensile force in the range of approximately 200-500grams is required to break the tack weld 49, and little or noparticulate matter is liberated with the breaking of the tack weld 49.As illustrated in FIG. 24, the outer tube 48 preferably includes a band105 viewable by the operator of the actuator that indicates when theactuator is properly inserted into the actuator 20, in the direction ofarrow 106. Specifically, when the outer tube 48 is inserted into theactuator 20, a correct depth of insertion is indicated when the marker105 is completely within the actuator 20 and no longer viewable by theoperator of the actuator, as illustrated in FIGS. 26A and 26B.

Alternatively, the biasing, fixing, and movement of the cord 52 withinthe positioner 40 can be achieved with a variety of designs. The slider50 can be threaded and received into corresponding threads of the outertube 48, with the slider 50 axially held in place relative to the outertube 48 by the threads, and with the biasing and movement of the slider50 controlled by the rotational movement of the slider 50 relative tothe outer tube 48. In another alternative, instead of the tack weld 49,the biasing of the cord 52 and the fixing of the slider 50 can beachieved with a removable locking pin fitted through a common holethrough the outer tube 48 and slider 50, temporarily fixed together withan adhesive or the pin can be breakable or bendable with a force that issimilar to the force applied when breaking the tack weld 49. The slider50 can also be temporarily fixed in place by a deformable crimp in theouter tube 48 that presses the outer tube 48 against the outer surfaceof the slider 50, to hold the slider 50 in place relative to the outertube 48.

In another alternative embodiment illustrated in FIG. 18, the slider 50is fixed to the outer tube 48 with a circumferential weld 74 instead ofthe tack weld 49 and the end weld 51 is replaced with an end cap 75 thatis similar to the end cap 82 at the implant interface 80, but having aport 76 that temporarily holds the cord 52 to the end cap 75 with a tackweld 77 similar to the tack weld 49. The proximal-most end of the cord52 is disposed proximal to the port 76. The tack weld 77 secures thecord 52 to the end cap 75 and maintains the positioner 40 in the engagedorientation until a predetermined proximally-directed force is appliedto the proximal-most portion of the cord 52 that is sufficient to breakthe tack weld 77. Alternatively, the end cap 75 and tack weld 77 can bereplaced with a ratchet mechanism that controls or limits movement ofthe cord 52 in the distal direction to maintain the engaged orientation,and that permits movement of the cord 52 in the proximal direction afterthe cord 52 is pulled in the proximal direction by a predetermined forcesimilar to the force required to break tack weld 77.

In another embodiment illustrated in FIG. 19, instead of the tack weld49, the slider 50 is connected to the outer tube 48 with acircumferential weld 74. The cord 52 is held in the center of thepositioner tube 42 along the axis 54 for the entire length of theproximal end of the positioner tube 42, with the proximal end of thecord 52 completely enclosed and held in the location of the axis 54 bythe slider 50, the positioner tube 42, and the cord liner 68. In theembodiment of FIG. 19, the external components of the proximal end ofthe positioner 40 are fixed to each other, but the internal cord 52remains slidably disposed along the axis 54 except at the proximal-mostend of the cord 52 where it is fixed at the end weld 51. The actuatorinterface 46 is of sufficient length so that the operator can hold andbend the actuator interface 46 around a cylindrical object (not shown),such as the operator's finger or a cylindrical object of a predetermineddiameter. When the actuator interface 46 is held against and wrappedaround the cylindrical object, the cord 52 is forced to conform to anarcuate path that has a radius that is greater than a radius of acorresponding arcuate path defined by the outer surfaces of thepositioner tube 42 and outer tube 48 that abut the cylindrical object,as measured from a center of the cylindrical object. As can beappreciated, the arcuate path of the cord 52 around the cylindricalobject is loner than the corresponding arcuate path at the outersurfaces of the positioner tube 42 and outer tube 48 abutting thecylindrical object, which induces a movement of the cord 52 (and amovement of the distal tip 88) in the proximal direction relative to theactuator interface 46 (and relative to the end cap 82) without the useof the actuator 20. The appropriate number of times that the proximalend of the positioner tube 42 must be wrapped around the cylindricalobject to cause sufficient movement of the distal tip 88 and achieve thedisengaged orientation can be determined by trial and error orcalculated for various sizes of the positioning system 10. In anotheralternative of the embodiment illustrated in FIG. 18, the outer tube 48and the slider 50 can be omitted and the positioner tube 42 and the cord52 can both directly engage the end weld 51.

In the embodiment illustrated in FIGS. 20A and 20B, the outer tube 48encloses bushings 101, 102, and 103 which are disposed within the outertube 48 and around the slider 50 and the positioner tube 42. Asillustrated, the bushing 101 is fixed to the inner surface of the outertube 48 with a circumferential weld at the proximal end of the outertube 48, and the slider 50 is slidably disposed within the inner surfaceof the bushing 101 but temporarily fixed to the bushing 101 with a tackweld 104 at the proximal end of the bushing 101. The tack weld 104functions similarly to the tack weld 49 described in the embodimentillustrated in FIG. 3. The bushing 102 is slidably disposed within theouter tube 48, and the distal end of the slider 50 is disposed withinthe bushing 102 and fixed to the bushing 102 with a circumferential weldat the distal end of the slider 50. The bushing 103 is fixed to theinner surface of the outer tube 48 with a circumferential weld at thedistal end of the outer tube 48, and the proximal end of the positionertube 42 is disposed within the inner surface of the bushing 103 andfixed to the bushing 103 with a circumferential weld at the distal endof the bushing 103. Features that are identical to the other embodimentsare not again identified.

When the implant interface 80 is in the engaged orientation, the slider50 is disposed in a distal position within the outer tube 48 andtemporarily held in place by the tack weld 104, as illustrated in FIG.20A. When desired by the operator, a predetermined force is applied tothe slider 50 in the proximal direction relative to the outer tube 48,and the tack weld 104 is broken to free the slider 50 to slidably movein the proximal direction within the bushing 101. The operator thenmoves the slider 50 into a proximal position illustrated in FIG. 20B,which corresponds to the disengaged orientation at the implant interface80. The slider 50 is retained in the outer tube 48 by the interferencebetween the bushing 102 and the bushing 101, thereby preventing theremoval of the slider 50 from the outer tube 48. In an alternative, thebushing 102 can be replaced with a flared distal end of slider 50 havingan outer diameter that is greater than the inner diameter of bushing101. In another alternative, the bushing 101 can be replaced by acrimped proximal section of the outer tube 48 that has an inner diameterthat is less than the outer diameter of the bushing 102, and the tackweld 104 can instead temporarily fix the proximal end of the outer tube48 to the exterior of the slider 50. In yet another alternative, a crimpcan be added to the outer tube 48 just distal of the bushing 101 toestablish an abutting surface that will impede the proximal movement ofthe bushing 102.

In yet another embodiment illustrated in FIG. 24, the outer tube 48preferably has a crimp 120 that forms an internal surface with adiameter that is less than the outer diameter of a portion of the slider50, so that when the slider moves in the proximal direction an edge 122abuts the inner surface formed by the crimp 120 and stops the furtherproximal movement of the slider 50. As also illustrated in FIG. 24, thepositioner 42 preferably includes one or more markers 124 on a sleeve126, which are preferably fluoro-safe markers. FIG. 25 illustratesanother embodiment functioning similarly to the embodiment of FIG. 24.Features that are identical to the other embodiments are not againidentified in FIGS. 24 and 25.

Actuator

The actuator provides a mechanism that removably engages the actuatorinterface and causes the controllable and predictable movement of theactuator interface. The actuator achieves this function by providing astructure that holds the outer tube in a fixed position relative to thebody of the actuator, and a pawl and anvil that pinches the slider andpulls the slider in the proximal direction for a predetermined distancewith a predetermined force, and then disengages from the slider to allowdisengagement from the actuator. The actuator also provides a designthat allows the operator to hold the actuator firmly in place, in orderto maintain the position of the positioner relative to the target site,and allows the operator to utilize the actuator in a controlled mannerthat minimizes the movement of the positioner.

As illustrated in FIG. 1, the proximal end of positioner 40 preferablyengages a distal end of the actuator 20. As illustrated in FIGS.21A-22B, the actuator 20 includes a body 21, a receiver section 22, apawl 23, an anvil 24, a slide return spring 25, a sliding frame 26, anda gripper 27. The body 21 is preferably tubular and provides support forthe proximal portion 26 a of the sliding frame 26, the receiver section22, and the slide return spring 25. Enclosing part of the body 21 is thegripper 27 which has two prongs that are pulled by the operator in theproximal direction when operating the actuator 20. The gripper 27 isfixed to a pin 28 that passes radially through the gripper 27, throughslot 29 in the body 21, and is fixed to the sliding frame proximalportion 26 a. The sliding frame proximal portion 26 a is also moveablyconnected to the proximal end of the body 21 by the slide return spring25. As can be appreciated from FIGS. 21A-22B, the sliding flame 26, thegripper 27, and the pin 28 are fixed to each other and move as one whenthe operator grasps the two prongs of the gripper 27 and the proximalend of the body 21 and slidably moves the gripper 27 in the distaldirection relative to the body 21 from the position illustrated in FIG.21A to the position illustrated in FIG. 21B.

FIGS. 21A and 22A illustrate the actuator 20 in a deactivated positionthat permits insertion of the actuator interface 46 into the actuator20. FIGS. 21B and 22B illustrate the actuator 20 in an activatedposition in which the slider 50 has been pulled in the proximaldirection relative to the outer tube 48 to cause the implant interface80 to move from the engaged orientation to the disengaged orientation.

As illustrated FIGS. 21A and 22A, the body 21 is preferably tubular, andhas a distal end connected to the receiver section 22, and an interiorlumen slidably containing the partly-cylindrical sliding frame 26. Thereceiver section 22 has a distal surface that includes a funnel thatdirects the insertion of the actuator interface 46 into a central lumen31. The central lumen 31 has two internal diameters adjacent to eachother along the length of the central lumen 31 that correspond to theouter diameters of the slider 50 and the outer tube 48, and an edgebetween the two diameters that functions as a stop when abutting theproximal end of the outer tube 48. The edge of the central lumen 31limits the proximal movement of the actuator interface 46 when insertedinto the central lumen 31, and orientates the slider 50 so that it isdisposed in a proximal direction from the central lumen 31 to apredetermined position between the pawl 23 and the anvil 24. Theproximal end of the body 21 has an enclosed end containing the slidereturn spring 25 under compression. The enclosed end of the body 21 alsoprovides a surface that the operator can hold in place when moving theprongs of the gripper 27 to change the actuator 20 from the deactivatedposition to the activated position. The slide return spring 25 alsoserves to return the actuator 20 to the deactivated position once theoperator releases the prongs of the gripper 27.

The receiving section 22 also includes a detent 32 fixed in a channeldirected radially into the receiving section 22 and into the centrallumen 31. The detail 32 includes a ball positioned in the channel thatis biased towards the central lumen 31 by an internal spring. A portionof the ball of the detent 32 is pressed into the central lumen 31 by theinternal spring and, when the actuator interface 46 is inserted into thecentral lumen 31, the ball presses against the outer surface of theouter tube 48 and frictionally retains the outer tube 48 in the centrallumen 31.

Slidably disposed in the interior of the body 21 is the sliding frame26. The proximal portion 26 a of the sliding frame 26 is sized toconform to the interior surface of the body 21, to align and guide themovement of the sliding frame 26 within the body 21. The sliding frame26 is biased in the body 21 to move in the distal direction by the slidereturn spring 25. The distal portion 26 b of the sliding frame 26engages the proximal portion 26 a (behind the pawl 23 and the anvil 24in the cross-sectional views presented in FIGS. 21A-22B) and abuts theproximal surface of the receiver section 22, and provides a generallyflat surface that is parallel to and adjacent to the portion of theslider 50 disposed proximal to the central lumen 31. The sliding framedistal portion 26 b is composed of two opposing members that extend fromthe cylindrical sliding frame proximal portion 26 a, with each memberdisposed on opposing sides of the pawl 23 and the anvil 24, to hold thepawl 23, the anvil 24, and a pawl spring 30 in position between the twoopposing members. In the cross-sectional views presented in FIGS.21A-22B, only the rear-most (of the view presented) of the two opposingmembers of the sliding frame distal portion 26 b is illustrated.

A hinge 33 also is disposed on the flat surface of the sliding framedistal portion 26 b (between the two opposing members of the slidingframe distal portion 26 b) and engages the pawl 23, and the pawl spring30 biases the proximal end of the pawl 23 away from the sliding frameproximal portion 26 a rotatably around the hinge 33, and presses theproximal end of the pawl 23 against the proximal end of the receiversection 22. The anvil 24 is carried by the flat surface of the slidingframe distal portion 26 b (between the two opposing members of thesliding frame distal portion 26 b) and, in the deactivated positionillustrated in FIGS. 21A and 22A, a space is maintained between the pawl23 and the anvil 24 sufficient to permit the insertion of the slider 50between the pawl 23 and the anvil 24.

Referring to FIGS. 21B and 22B, when the sliding frame 26 is moved apredetermined distance in the proximal direction relative to the body 21and away from the receiving section 22, the pawl 23 and anvil 24 alsomove because they are engaged to the sliding frame distal portion 26 b.The proximal movement of the sliding frame 26 also causes the proximalend of the pawl 23 to rotate around hinge 33 because of the bias frompawl spring 30, which is under compression, and causes the distal end ofthe pawl 23 to press the slider 50 against the anvil 24, therebypinching and securing the slider 50. The slider 50, now secured betweenthe pawl 23 and the anvil 24, is pulled in the proximal direction by theproximal movement of the sliding frame 26, while the outer tube 48 isretained by the edge within the central lumen 31 of the receiver section22, thereby causing the tack weld 49 to break and move the implantinterface 80 into the disengaged orientation. As illustrated in FIGS.21B and 22B, the slider 50 is ultimately moved in the proximaldirection, relative to the outer tube 48, by almost the same distancetraveled by the anvil 24 and the sliding frame 26 in the proximaldirection relative to the body 21 and the receiver section 22.

More preferably, the receiver section 22 is made of polycarbonate orABS, and the pawl 23, the anvil 24, the slide return spring 25, and thepawl spring 30 are made of steel. Also more preferably, the funnel ofthe receiver section 22 is a cone with an angle of 10-120 degrees, andthe central lumen 31 has a diameter of 0.010-0.030 of an inch to receivethe outer tube 48 and a diameter of 0.006-0.026 of an inch to receivethe slider 50.

Most preferably, the receiver section 22 is made of polycarbonate, andthe pawl 23, the anvil 24, the slide return spring 25, and the pawlspring 30 are made of stainless steel. Also most preferably, the funnelof the receiver section 22 is a cone with an angle of 30 degrees, andthe central lumen 31 has a diameter of 0.018 of an inch to receive theouter tube 48 and a diameter of 0.014 of an inch to receive the slider50.

The operator-manipulated interface surface used by the operator to movethe actuator 20 from the deactivated position, illustrated in FIG. 21A,to the activated position, illustrated in FIG. 21B, can be implementedwith a variety of alternative designs that provide the structurenecessary to move the sliding frame 26 proximally relative to thereceiver section 22 (i.e., the gripper 27 and the prongs disposed on thegripper 27 can be replaced with alternative structures that cancontrollably move the internal components within gripper 27 asillustrated in FIGS. 21A and 22B). In the embodiment illustrated in FIG.1, and as illustrated in FIGS. 21A-22B, the actuator 20 involves theoperator compressing the actuator 20 so that the prongs of the gripper27 (fixed to the sliding frame 26) are moved proximally in relation tothe proximal end of the body 21 (fixed to the receiver section 22). Inalternative embodiments, instead of the operator compressing theactuator 20 with the gripper 27, the internal components (i.e., thecomponents within gripper 27) of the actuator 20 remain essentially thesame, but the external components interfacing with the operator areadapted to facilitate a variety of actuating motions, such as theactuating motions of squeezing a trigger, sliding a switch, turning awheel, pushing a button, or moving a lever. Another embodiment of theactuator 20 is illustrated in FIGS. 27 and 28, with features identicalto the other embodiments not identified again. As illustrated in FIG.27, the body 21 is held by the operator and the gripper 27 is slid inthe proximal direction to move the actuator 20 from the deactivatedposition to the activated position illustrated in FIG. 27.

Pushability

The vasculature of the brain is more tortuous than the vasculatureleading to the brain from the groin, a typical access point into apatient's body. An instrument disposed in a patient's body between thegroin and the brain thus experiences the most tortuous pathway at thedistal end of the instrument. This tortuous pathway forces theinstrument to bend and subjects the instrument body to increasedstresses. Also, any sliding member slidably moved within the instrument,such as a cord, is subjected to greater frictional forces against thesides of the instrument when the instrument is bent or curved. Theseincreased frictional forces require the operator of the instrument toexert additional force to move the sliding member through theinstrument, and the increased stresses on the instrument from bends orcurves can cause permanent deformation of the instrument or failure ofthe instrument body or sliding member. Also, high frictional forces atthe distal end of the instrument body can impede the movement of theinstrument through a catheter, or the movement of a cord through theinstrument. Namely, high frictional forces at the distal end of theinstrument can cause the middle and proximal portions of the slidingmember or cord to buckle, i.e., to have the axial movement of thesliding member or cord redirected in a undesirable non-axial or radialdirection instead of a desired axial direction, or form kinks in thesliding member or cord.

In order to minimize the force required from the operator, and to lessenthe potential for failure of instrument components, the positioningsystem advantageously achieves improved “pushability.” Specifically,pushability can be characterized by a ratio of the force applied to thepositioner or cord by the operator at the proximal end of the system(“F1”) and the force observed at the distal end of the system (“F2”).Ideally, when the ratio of F1 to F2 approaches unity, this indicatesthat the force applied, to the proximal end translates to an equal ornear equal force at the distal end. As can be appreciated, buckling orkinking of the positioner or cord would produce a ratio of F1 to F2 thatis not at or not near unity. The ratio of F1 to F2 can also berepresented as a percentage, indicating that a certain percentage of theforce at the proximal end was observed at the distal end. As shown inTable 1, the positioning system 10 preferably provides a pushabilitythat is nearer to unity (100%) than that observed with an existingdelivery system (“Nexus/NXT Pusher” refers to a pusher used with theNexus™ and, NXT™ coils, commercially available from EV3, Inc. ofPlymouth, Minn. USA).

TABLE 1 Sample System Average pushability Standard deviation Positioningsystem 94.6% 1.9% Nexus/NXT Pusher  79% 4.6%

The positioning system also advantageously achieves improved“pushability” or “slidability” by reducing friction between the cord 52and the positioner tube 42, and between the positioner tube 42 and themicrocatheter 14. The following equation is a characterization of thefrictional forces relating to a flexible inner cylindrical memberenclosed within a flexible outer cylindrical member, with the outermember conforming to a curved surface defining a tortuous path, and withthe inner member slidably moved within the outer member:F ₁ /F ₂ =e ^(μΘ)  Equation (3)where,

-   -   F₁ is the force applied to the inner member at a proximal end of        the interface between the inner and outer tubes over the length        of the tortuous path,    -   F₂ is the resisting force exerted by the outer member at a        distal end of the interface between the inner and outer tubes        over the length of the tortuous path,    -   e is the base of natural logarithms,    -   μ is the average coefficient of friction along the length of the        interface between the inner and outer tubes over the length of        the tortuous path, and    -   Θ is total tortuosity over the length of the tortuous path,        i.e., the sum of angular contact between the inner member and        the outer member, in radians.        The smallest force transfer ratio (F₁/F₂) possible is desired so        that there is only a small frictional loss related to the        movement between the inner and outer tubes. As it is well known        that e⁰=1, it can be appreciated that, in order for the force        transfer ratio to be as small as possible, the product of μ and        Θ must likewise be a small value.

When the principles of Equation (3) and knowledge of vasculature anatomyare applied in the various embodiments, an advantageous force transferratio is achieved by reducing the average friction coefficient at theportions of the positioning system 10 subject to the greatesttortuosity. This is achieved by preferably selecting specific materialsand surface characteristics of mating surfaces at the portions of thepositioning system 10 subject to the greatest tortuosity, preferably inthe distal-most third of the positioner 40. More preferably, thepositioning system 10 performs within a range of tortuosity of 900-4000degrees, with a force transfer ratio of 16 or less, and an averagefriction coefficient of 0.045 or less over the length of the 4000-degreetortuous path. Most preferably, the positioning system 10 performswithin a range of tortuosity of 2000-4000 degrees, with a force transferratio of 16 or less, and an average friction coefficient of 0.045 orless over the length of the 4000-degree tortuous path.

Materials capable of providing a friction coefficient of 0.045 or lessare limited. Preferably, the cord 52 is a stainless steel cord with aroughness of less than 50 microinches and the cord liner 68 is a polymerwith a roughness of less than 200 microinches, the cord liner 68 and thecord 52 has a hydrophilic coating, or the space between the cord liner68 and the cord 52 is loaded with a liquid polysiloxane containing aconcentration of stearic acid in the range of 2-10%. More preferably,the cord 52 is a 304 stainless steel cord with a roughness of less than50 microinches and the cord liner 68 is PTFE with a roughness of lessthan 200 microinches.

Preferably, the materials for the cord 52 and the cord liner 68 are usedfor the entire lengths of the cord and cord liner. However, thepreferred materials need only be provided in the portions of thepositioner 40 that are subjected to the 4000 degrees of tortuosity,which is mostly the distal third of the positioner 40. For the proximaltwo thirds of the positioner 40, a wider selection of materials isavailable because this portion of the positioner 40 is subjected to lesstortuosity (less than 2000 degrees) than the distal third of thepositioner 40. Preferably, for the proximal two thirds of the positioner40, the positioner 40 performs with a force transfer ratio of 15 or lessand an average friction coefficient of 0.11 or less over the length of a2000 or less-degree tortuous path in the proximal two thirds of thepositioner 40. The materials capable of providing a friction coefficientof 0.11 or less are not as limited as with the distal third of thepositioner 40. Preferable materials suitable for use in the proximal twothirds of the positioner 40 include polyethylene, acetal, orfluoropolymer for the cord liner 68, and a steel or polymer materialwith a surface roughness of less than 50 microinches for the cord 52.More preferably materials are polyethylene for the cord liner 68 andsteel with a surface roughness of less than 50 microinches for the cord52.

An advantageous force transfer ratio is also achieved at another matingsurface of the positioning system 10, i.e., where the positioner tubesleeve 66 slidably moves within the microcatheter 14. Applying the sameprinciples of Equation (3) as described above for the cord 52 and thecord liner 68, the preferred material for the positioner tube sleeve 66is a PTFE heat shrunk material and the preferred material for themicrocatheter 14 is a polymer with a relatively smoother surface.

Flexibility

The flexibility of the positioning system along the length of the systemcan affect system design and performance, as the flexibility of thesystem relates to the ability of the operator to control the positionerand the “feel” of the system from the proximal end manipulated by theoperator. Also, the suppleness of the distal tip of the positionerrelates to the ability of the operator to direct the positioner into thedesired position. Maintaining the desired flexibility of a system with amechanical implant engagement and disengagement system is particularlydifficult because the length of the system must provide a mechanicalconnection between the proximal and distal ends of the system that isboth small in size but strong enough to cause the engagement anddisengagement of the implant from the system.

The positioning system achieves the appropriate level of flexibility bypreferably providing a relatively rigid structure at the proximalportion of the positioner, a relatively supple structure at the distalportion the positioner, and a transition region in the middle of thepositioner that provides a change in flexibility between the proximaland distal portions. The proximal portion of the positioner preferablyprovides a flexibility (or stiffness) that remains almost constant alongthe length of this section of the positioner. The near-constantflexibility of the proximal portion is achieved by the use of a tubestructure. The distal portion and the transition region achieve asuppleness with a combination of structural modifications to the tubestructure that increases flexibility, the increase in the degree ofthose structural modifications along the length of the tube structure inthe distal direction, and the structural support provided to thepositioner by reinforcing structures. The flexibility of the distalportion increases along the length of this section, with the greatestsuppleness achieved near or at the distal-most end of the positioner.More preferably, the near-constant flexibility of the proximal portionis achieved by a fully-enclosed tube structure of the positioner withoutthe use of skiving. The variable flexibility characteristics of thedistal portion and the transition region are achieved by a combinationof a tube with skiving, the increase in the degree of the skiving alongthe length of the tube in the distal direction, and the structuralsupport provided to the positioner by the positioner tube sleeve.

FIG. 23A illustrates the flexibility of the positioner 40 of theembodiment illustrated in FIGS. 3 and 4 (identified as “3G/FX-0.012”Prox Pusher” in FIGS. 23A and 23C). The horizontal axis in FIG. 23A(labeled “distance from target site”) corresponds to the length of thepositioner 40, with the end cap 82 (proximate to or within the area ofthe target site, as illustrated in FIG. 2C) defining the zero point onthe horizontal axis and each marking on the horizontal axis identifyinga distance from the end cap 82 in the proximal direction. The horizontalaxis also corresponds to the anatomical areas in the human bodyillustrated in FIG. 2A when the end cap 82 is disposed near the targetsite 16, with distances proximal from the end cap 82 and target site 16corresponding to the various anatomical features identified in FIG. 23Auntil the proximal end of the positioner 40 ultimately exits the humanbody at the groin as illustrated in FIG. 2A. The vertical axis in FIG.23A (labeled “moment”) corresponds to the amount of resistance providedby the positioner 40 along its length when subjected to a 20°deflection.

When subjected to a 20° deflection, the positioner 40 resists thedeflection, which corresponds to flexibility, by generating a moment. Asillustrated in FIG. 23A, the moment observed at the proximal portion ofthe positioner 40 is approximately constant proximal to the portion ofthe positioner 40 disposed near the aorta, indicating a near-constantflexibility in this portion of the positioner 40. The moment observed atthe distal portion of the positioner 40 decreases distal to the portionof the positioner 40 disposed in the carotid artery, indicating avariable flexibility in this portion of the positioner 40 that increasesin the distal direction. As also illustrated in FIG. 23A, the momentchanges at an approximately linear rate in the transition region of thepositioner 40 that corresponds to a length of the positioner 40 disposedbetween the aorta (approximately) and carotid artery (approximately),indicating an approximate linear change in flexibility in this portionof the positioner 40, front a lesser flexibility to a greaterflexibility in the distal direction. The near-constant flexibility inthe proximal portion of the positioner 40, and the approximately linearchange in positioner flexibility in the transition region, provides acombined flexibility that is interpreted as a good “feel” to theoperator manipulating the outer tube 48. The flexibility profileillustrated in FIG. 23A also advantageously provides a relatively suppledistal end in the tortuous anatomy within the brain and distal to thecarotid artery. The relatively stiff proximal end provides the operatorthe ability to control the positioner 40. Also, the portion of thepositioner 40 where the greatest transition from rigid to supple takesplace (in the transition region) is disposed as distal as possible inthe positioner 40, but just proximal of the carotid artery where theanatomy begins to become more tortuous towards the brain and whereincreased suppleness is desired.

As also illustrated in FIG. 23A, the positioner 40 provides a variableflexibility profile over the length of the positioner 40. At theproximal portion of the positioner 40, the moment measured preferably is0.01-0.50 in-lbs at 20° of deflection between the proximal end of thepositioner 40 and the portion of the positioner 40 disposed near theaorta, between 55 cm and 80 cm proximally from the target site 16. Atthe distal portion of the positioner 40, the moment measured preferablyis 0.0001-0.0100 in-lbs at 20° of deflection between the portion of thepositioner 40 disposed in the carotid artery and the end cap 82, between0 cm and 35 cm proximally from the target site 16. At the transitionregion of the positioner 40 between the proximal and distal portions,the moment measured preferably changes from 0.001 in-lbs to 0.100 in-lbsat 20° of deflection between 35 cm and 50 cm from the target site 16.More preferably, the flexibility of the proximal portion isapproximately 0.045 in-lbs at 20° of deflection, the flexibility of thetransition region changes form 0.0005 to 0.045 in-lbs at 20° ofdeflection, and the flexibility of the distal portion is approximately0.0005 in-lbs at 20° of deflection.

As further illustrated in FIG. 23A, the flexibility of the positioner 40changes at specific rates over the length of the positioner 40, asdetermined from the measurement of moment in the positioner 40. At theproximal portion of the positioner 40, the flexibility preferably doesnot change between the proximal end of the positioner 40 and the portionof the positioner 40 disposed near the aorta, between 55 cm and 80 cmproximally from the target site 16. At the distal portion of thepositioner 40, the flexibility preferably changes at a rate of 100-800%between the portion of the positioner 40 disposed in the carotid arteryand the end cap 82, between 0 cm and 35 cm proximally from the targetsite 16. At the transition region of the positioner 40 between theproximal and distal portions, the flexibility preferably changes at arate of 100-1000% between 35 cm and 55 cm from the target site 16. Morepreferably, the flexibility of the proximal portion is constant, theflexibility of the transition region changes at a rate of approximately800%, and the flexibility of the distal portion changes at a rate ofapproximately 700%.

As illustrated in FIG. 23B, the flexibility profiles of existingthermal, electrolytic, and hydraulic systems are comparable to theflexibility profile of the embodiment illustrated in FIGS. 3 and 4 (InFIGS. 23B and 23C, “Cordis” refers to Cordis Corporation of Miami Lakes,Fla. USA, “MTI” refers to Micro Therapeutics, Inc. of Irvine, Calif.USA, “GDC” refers to the Guglielmi Detachable Coil or GDCID® DetachableCoil commercially available from Boston Scientific Corporation ofNatick, Mass., USA, and “Micrus” refers to Micrus EndovascularCorporation of San Jose, Calif. USA). As can also be appreciated from acomparison of FIGS. 23A and 23B, the illustrated embodiment has a lessflexible proximal portion, between the proximal end of the positioner 40and the portion of the positioner disposed near the aorta, than existingthermal, electrolytic, and hydraulic systems.

FIG. 23C is a closer and more detailed view of the information presentedin FIGS. 23A and 23B, between the distances of 0 and 40 cm (on thex-axis) and between the moments of 0.000 and 0.005 in-lbs (on they-axis). As can be seen in FIG. 23C, in the distal portion of thepositioner 40, between 0 and 35 cm from the end cap 82 (or from thedistal ends of the respective existing systems), the moment observeddecreases (and the flexibility of the positioner 40 increases)continuously until reaching the last 4 cm, where measurements becomeless reliable. As can also be seen in FIG. 23C, the existingnon-mechanical systems of FIG. 23B produce a moment that does not changebetween 10 and 35 cm and that quickly reduces to a minimal momentbetween 0 and 10 cm. It is believed that this comparatively abruptchange in moment in the distal-most 10 cm of existing devicesdemonstrates that existing devices do not have continuously varyingflexibility in their respective distal portions. The positioner 40 ofthe illustrated, embodiment, however, has a flexibility that changescontinuously along the length of the distal portion, and especiallybetween the 5-35 cm proximal to the end cap 82. As can also be seen fromFIG. 23C, the distal end of the positioner 40 provides a flexibilitythat changes in the distal direction by 100-800% between 35 cm and 0 cmfrom the end cap 82, and more preferably changes by approximately 700%.As can also be seen from FIG. 23C, the distal end of the positioner 40provides a flexibility that changes in the distal direction between 35cm and 10 cm from the end cap 82, decreasing by 100-900%, and morepreferably by 500%. Referring to FIG. 23C, it is believed that existingnon-mechanical systems do not provide distal portions with flexibilitiesthat change as significantly as seen with the positioner 40, and it isalso believed that existing non-mechanical systems do not provide distalportions with flexibilities that change between 10 and 35 cm from thedistal-most end of these systems.

The flexibility of the tip of the positioner 40 is important to properpositioning of the implant 90 at the target site 16. The distal tipflexibility of the embodiment illustrated in FIGS. 3 and 4 has beendemonstrated to provide a more flexible tip as compared to other systemswhen subjected to a longitudinally compressive force, as shown in Table2.

TABLE 2 Sample System Buckling Force Positioning system 1.0 g MicrusPusher 3.0 gProfile

A mechanically-operated positioning system must be flexible and smallenough to reach the target site, but remain strong enough to permit theoperator to control the positioning and mechanical operation of theimplant interface. The positioning system achieves amechanically-operated implant engagement and disengagement system withan appropriate profile, or size, by utilizing materials and surfaceswith variable friction coefficients, strengths, and flexibilitiesappropriate for a positioner subjected to a tortuous pathway.Preferably, the outer diameter of the distal end of the positioner 40,at the distal end of the pusher tube 42, is small enough to reach thetarget site 16 while permitting the proper operation of the implantinterface 80 from a mechanical system connecting the implant interface80 to the proximal end of the positioning system 10. More preferably,the outer diameter of the distal end of the positioner 40, at the distalend of the pusher tube 42, has a 0.008-0.018 inch outer diameter, for304 stainless steel hypotube or steel alloy. Most preferably, the outerdiameter of the distal end of the positioner 40, at the distal end ofthe pusher tube 42, has a 0.012 inch outer diameter, for 304 stainlesssteel hypotube.

Fatigue Resistance

When implanting multiple neurological coils in an aneurysm, it isbelieved that a common practice is to place multiple coils within theaneurysm sufficient to occupy the void created by the aneurysm and topromote the formation of thrombi. It is also believed that asatisfactory result can be achieved when an aneurysm accommodates asmany coils as possible, within the discretion of the operator. However,in such a procedure, it is possible that the coil or coils implantedfirst can interfere with or impeded the placement of subsequent coils.Also, this interference from already-implanted coils can possibly makeit difficult for the operator to determine whether the aneurysm canaccommodate additional coils. The placement of too few coils canpossibly affect performance, and the placement of too many coils couldpossibly result in the rupture of the aneurysm or the dislodgement of acoil from a desired position at the target site.

It is further believed that when positioning an additional coil at thetarget site, the operator may repeatedly move the additional coil backand forth (by moving the delivery system) in order to nest the coilwithin the aneurysm between the already-implant coils, and to evaluatewhether the aneurysm can accommodate the implantation of more coils. Itis also believed that the repeated movement of the delivery system andadditional coil causes the system and coil to experience friction wherethe system and coil slidably move within a delivery catheter and wherethe additional coil contacts already-implanted coils. It is believedthat the friction from the repeated movement of the system and coil cancause the connection point between the system and coil to experiencesignificant stresses and, when combined with the repeated back-and-forthmovement, possibly cause material fatigue and the fracture of theconnection point, resulting in the premature disengagement of the coilfrom the system. It is further believed that existing delivery systemsthat rigidly or firmly engage the additional coil, or that impede thefree movement or rotation of the coil relative to the system, permit thedevelopment of the stresses relating to the repeated back-and-forthmovement of the system and coil.

The positioner of the various embodiments avoids or minimizes thedevelopment of stresses at the interface between the positioner andimplant by permitting the unrestrained movement of the implant relativeto the positioner, within the limitations defined by the implantinterface. The development of implant interface stresses is minimized oravoided because the ball, rod, and implant are able to move in the axialand radial directions compared to the axis of the positioning system, torotate about an axis of the rod or implant, and to move angularly sothat implant is at an angle as compared to the axis of the positioningsystem.

Referring to FIG. 13, when subjected to a back-and-forth (or push-pull)movement during an implantation procedure, a proximal movement (or pull)of the positioner 40 causes the implant interface 80 to engage and pullthe ball 96 and pull the implant 90 in a proximal direction, which maycause stresses at the ball 96 and rod 94 when the implant 90 resists theproximally-directed movement because of friction from contact with theinside of the microcatheter 14 or with already-implanted implants.However, because the ball 96 and rod 94 are able to move within the endcap 82, the implant 90 is able to assume an orientation, angulation, orrotational position that prevents or minimizes the development ofstresses from the bending or turning of the implant 90 relative to thepositioner 40.

Referring to FIG. 12, a distal movement (or push) of the positioner 40causes the distal surface of the implant interface 80 (the end cap 82)to engage and push the proximal surface of the implant 90 and push theimplant 90 itself in the distal direction, without applying axiallydirected forces to the ball 96 or rod 94. The ball 96 and rod 94 arethus not subjected to a significant stress when the implant 90 is movedin the distal direction because all or a majority of the force impartedfrom the positioner 40 to the implant 90 is imparted directly to theimplant 90 without the involvement of the ball 96 or rod 94, althoughthere may be some radially directed forces applied to the ball 96 or rod94 by contact with the end cap 82 or positioner 40. In the distalmovement of the positioner 40 and implant 90, the implant 90 remainscapable of assuming an orientation or rotational position responsive toforces resulting from the contact of the implant 90 with the end cap 82,with the inside of the microcatheter 14, or with already-implantedimplants. Also, because the implant 90 abuts the end cap 82, theoperator is provided with a tactile sensation regarding the degree ofresistance resulting from attempts to insert or nest the implant 90within the aneurysm or among the already-implanted implants.

As shown in Table 3, when measured, it has been observed that theengagement between the rod 94 and the positioner 40 can withstandgreater tensile force than the interfaces between the implants connectedto existing systems (“Positioner/Implant Interface” refers to thedescribed embodiment, “Sapphire/NXT/Nexus” refer to the Sapphire™, NXT™,and Nexus™ products commercially available from EV3, Inc. of Plymouth,Minn. USA, and “GDC” refers to the Guglielmi Detachable Coil or GDC®Detachable Coil commercially available from Boston ScientificCorporation of Natick, Mass., USA).

TABLE 3 Positioner/Implant Sapphire/NXT/ GDC - System Interface NexusElectrolytic mean force 1.71N 1.62N 1.02N standard deviation 0.06N 0.18N0.17N 95/95 1.53N 0.95N 0.38NDetachment Time

The embodiment illustrated in at least FIGS. 3 and 4 provides a coilpositioning system 10 that are preferably already in the engagedorientation when removed from packaging and prior to insertion into apatient, as illustrated in FIG. 8A for example. The illustratedpositioner 40 and implant 90 thus provide a system that is ready for useout of the package, subject of course to the requisite steps common tosuch medical procedures that must be performed before deploying thecoil, e.g., the insertion of a microcatheter into the patient and theinsertion of the delivery system into the microcatheter.

The embodiment illustrated in at least FIGS. 3 and 4 also provides acoil positioning system that directly connects the actuation of thedetachment mechanism with the detachment of the implant from thedelivery system, without an intermediary process that must initiate andcomplete to achieve coil detachment. As illustrated in FIGS. 3-4 and8A-8C, the direct connection between slide 50 and cord 52 causes themovement of the slider 50 to move the cord 52 away from the port 84,thereby achieving a detached status because the implant 90 is no longersecurely retained by the positioner 40, as the ball 96 is free to passthrough port 84. Also, the coil structure of the illustrated implant 90further facilitates the movement of the ball 96 through port 84 becausethe coil structure expands or adjusts to the anatomy of the target site16, which causes the implant 90 to move distally away from the end cap82 and thereby facilitate the movement of the ball 96 through the port84. Preferably, the illustrated embodiment achieves an out-of-packagepreparatory time of approximately 15 seconds and a detachment time ofless than 1 second.

It is believed that preparatory and detachment times of the illustratedembodiment provide a system that permits a fast and efficient deploymentof implants at a target site. The advantageous preparatory anddetachment times reduce the length of time required to prepare thepositioning system and advantageously increases the efficiency of theprocedure, thereby allowing the practitioner to attend to other dutiesduring the invasive medical procedure.

While the present invention has been disclosed with reference to certainembodiments, numerous modifications, alterations, and changes to thedescribed embodiments are possible without departing from the sphere andscope of the present invention, as defined in the appended claims.Accordingly, it is intended that the present invention not be limited tothe described embodiments, but that it has the full scope defined by thelanguage of the following claims, and equivalents thereof.

What is claimed is:
 1. An assembly for deploying an implant into ananeurysm in a vessel, comprising: a distal region of a tubular memberhaving a longitudinal axis, a circumferential wall defining only onelumen along the axis, the lumen having a lumen cross-sectionaldimension, and the distal region having only one aperture from thelumen, the aperture being disposed in a distal portion and having aninner cross-sectional dimension less than the lumen cross-sectionaldimension, and a distal end; a coil implant having an enlarged proximalend disposed within the lumen of the distal region, wherein at least aportion of the coil implant extends through the aperture; a core wireextending within the lumen and contacting (a) the circumferential walland (b) the enlarged end at a point proximal to the distal portion; andwherein a length of a line segment extending from an outer surface ofthe enlarged end, through the point, and to an outer surface of the corewire is greater than the inner cross-sectional dimension, such that theenlarged end is prevented from moving within the lumen distally entirelypast the distal end when the core wire and enlarged end are positionedradially adjacent each other within the lumen; and wherein, when theenlarged end is disposed within the lumen, the core wire extendsdistally beyond a distal end of the enlarged end to the tubular memberdistal portion.
 2. The assembly of claim 1, wherein the core wireextends beyond a distalmost portion of the lumen.
 3. The assembly ofclaim 1, wherein the coil implant further comprises a coil having aproximal portion and a distal portion.
 4. The assembly of claim 3,wherein the coil implant further comprises a stretch-resistant memberextending through the coil and having a proximal end and a distal end,the stretch-resistant member distal end coupled to the coil distalportion.
 5. The assembly of claim 4, wherein the enlarged proximal endis disposed at the proximal end of the stretch-resistant member and isotherwise free of the proximal portion of the coil.
 6. An assembly fordeploying an implant into an aneurysm in a vessel, comprising: a distalregion of a tubular member having a longitudinal axis, a circumferentialwall defining only one lumen along the axis, the lumen having a lumencross-sectional dimension, and the distal region having only oneaperture from the lumen, the aperture being disposed in a distal portionand having an inner cross-sectional dimension less than the lumencross-sectional dimension, and a distal end; a coil implant comprising:(i) a coil; (ii) an enlarged proximal end spaced apart from the coil anddisposed within the lumen of the distal region, wherein at least aportion of the coil implant extends through the aperture; a core wireextending within the lumen and contacting (a) the circumferential walland (b) the enlarged end at a point, the core wire extending into theport; and wherein a length of a line segment extending from an outersurface of the enlarged end, through the point, and to an outer surfaceof the core wire is greater than the inner cross-sectional dimension,such that the enlafrged end is prevented from moving within the lumendistally entirely past the distal end when the core wire and enlargedend are positioned radially adjacent each other within the lumen.
 7. Theassembly of claim 6, wherein the coil further comprises a proximalportion and a distal portion.
 8. The assembly of claim 7, wherein thecoil implant further comprises a stretch-resistant member extendingthrough the coil and having a proximal end and a distal end, thestretch-resistant member distal end coupled to the coil distal portion.9. The assembly of claim 8, wherein the enlarged proximal end isdisposed at the proximal end of the stretch-resistant member and isotherwise free of the proximal portion of the coil.
 10. The assembly ofclaim 6, wherein, when the core wire and enlarged proximal end arepositioned radially adjacent each other relative to the axis, theenlarged proximal end abuts the wall.
 11. The assembly of claim 6,wherein, at the distal portion, the wall comprises at least one sectionextending at least partially through the wall.
 12. The assembly of claim11, wherein, the at least one section is selected from the groupconsisting of a skived section, a slot, a gap, a hole, a spiral cut, anda reduced thickness in the tubular wall.
 13. An assembly for deployingan implant into an aneurysm in a vessel, comprising: a distal region ofa tubular member having a longitudinal axis, a wall defining only onelumen along the axis, and the distal region having only one aperturefrom the lumen, the aperture being disposed in a distal portion andhaving an inner cross-sectional dimension and a distal end; a coilimplant comprising: (i) a coil disposed entirely outside the lumen; (ii)an enlarged proximal end disposed within the lumen of the distal region,wherein at least a portion of the coil implant extends through theaperture; a core wire extending within the lumen and contacting (a) thecircumferential wall and (b) the enlarged end at a point proximal to thedistal portion; and wherein a length of a line segment extending from anouter surface of the enlarged end, through the point, and to an outersurface of the core wire is greater than the inner cross-sectionaldimension, such that the enlarged end is prevented from moving withinthe lumen distally entirely past the distal end when the core wire andenlarged end are positioned radially adjacent each other within thelumen; wherein the lumen has a lumen cross-sectional dimension and thetubular member comprises a reduced portion proximal to the enlargedproximal end, having an opening receiving a portion of the core wire,the opening having a reduced cross-sectional dimension less than thelumen cross-sectional dimension.
 14. The assembly of claim 13, whereinthe coil further comprises a proximal portion and a distal portion. 15.The assembly of claim 14, wherein the coil implant further comprises astretch-resistant member extending through the coil and having aproximal end and a distal end, the stretch-resistant member distal endcoupled to the coil distal portion.
 16. The assembly of claim 15,wherein the enlarged proximal end is disposed at the proximal end of thestretch-resistant member and is otherwise free of the proximal portionof the coil.
 17. The assembly of claim 13, wherein, when the core wireand enlarged proximal end are positioned radially adjacent each otherrelative to the axis, the enlarged proximal end abuts the wall.
 18. Theassembly of claim 13, wherein, at the distal portion, the wall comprisesat least one section extending at least partially through the wall. 19.The assembly of claim 18, wherein, the at least one section is selectedfrom the group consisting of a skived section, a slot, a gap, a hole, aspiral cut, and a reduced thickness in the tubular wall.
 20. An assemblyfor deploying an implant into an aneurysm in a vessel, comprising: adistal region of a tubular member having a longitudinal axis, a walldefining only one lumen along the axis, and the distal region havingonly one aperture from the lumen, the aperture being disposed in adistal portion and having an inner cross-sectional dimension and adistal end; a coil implant comprising: (i) a coil having a proximalportion and a distal portion; (ii) a stretch-resistant member extendingthrough the coil and having a proximal end and a distal end, thestretch-resistant member distal end coupled to the coil distal portion;(iii) an enlarged proximal end disposed at the proximal end of thestretch-resistant member and otherwise free of the proximal portion ofthe coil and disposed within the lumen of the distal region, wherein atleast a portion of the coil implant extends through the aperture; a corewire extending within the lumen and contacting (a) the circumferentialwall and (b) the enlarged end at a point; and wherein a length of a linesegment extending from an outer surface of the enlarged end, through thepoint, and to an outer surface of the core wire is greater than theinner cross-sectional dimension, such that the enlarged end is preventedfrom moving within the lumen distally entirely past the tubular memberdistal end when the core wire and enlarged end are positioned radiallyadjacent each other within the lumen; wherein the lumen has a lumencross-sectional dimension and the tubular member comprises a reducedportion proximal to the enlarged proximal end, having an openingreceiving a portion of the core wire, the opening having a reducedcross-sectional dimension less than the lumen cross-sectional dimension.21. The assembly of claim 20, wherein, when the core wire and enlargedend are positioned radially adjacent each other relative to the axis,the enlarged proximal end abuts the wall.
 22. The assembly of claim 20,wherein, at the distal portion, the wall comprises at least one sectionextending at least partially through the wall.
 23. The assembly of claim22, wherein, the at least one section is selected from the groupconsisting of a skived section, a slot, a gap, a hole, a spiral cut, anda reduced thickness in the tubular wall.